184 Study Manager jobs in Ireland

RecruitNet International Ltd   Specializing in relocating qualified professionals throughout Ireland and overseas, we guide you through the We the RecruitNet team are always on call to help you find your perfect job and are staffed by highly experienced and professional nursing recruitment consultants.  Provide clinical treatment to patients with varying degrees of heart failure as a member of a multidisciplinary team, this role will prioritize research and the provision of healthcare services.Research initiatives in cardiac therapy.Participant recruiting, database administration, and study visit coordination will all be a part of this multidisciplinary team role. RequirementsBe on the live register with NMBI.Minimum of 5 years post-registration experience. Strong interpersonal & communication skills.A minimum of two years at least after registration in a treatment field related to cardiology.Capabilities in management and leadership.BenefitsFully Funded Private Health InsuranceGenerous SalariesEducational SupportExcellent Career OpportunitiesProvide exceptional patient care in an environment where quality, respect, caring, and compassion are at the centre of all that we do.

This role is an onsite position in one of our office locations. This role is not eligible to be fully remote. The Manager Clinical Study Lead (CSL) may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out. The CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study Provides operational input into protocol development Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensures compliance with the clinical trial registry requirements Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors Provides input into baseline budget development and management Provides input into baseline timeline development and management Leads risk assessment and identifies risk mitigation strategies at the study level Leads the feasibility assessment to select relevant regions and countries for the study Oversees/conducts site evaluation and selection Leads investigator meeting preparation and execution Monitors progress for site activation and monitoring visits and acts on any deviations from plan Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Monitors data entry and query resolution and acts on any deviations from agreed metrics Ensures accurate budget management and scope changes for internal and external studies Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Escalates issues related to study conduct, quality, timelines or budget to Program Operations Lead (POL) and other stakeholders and develops and implements appropriate actions to address issues Oversees the execution of the clinical study against planned timelines, deliverables and budget Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work Ensure clinical project audit and inspection readiness through the study lifecycle Supports internal audit and external inspection activities and contributes to CAPAs as required Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability Contributes to clinical study report writing and review Facilitates and contributes to study level lessons learned Assigns tasks to Clinical Study Management staff and supports their deliverables Recommends and participates in cross-functional and departmental process improvement initiatives Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring May require up to 25% travel This role may be for you if you have: Demonstrated interpersonal & leadership skills Ability to understand and implement the operational strategic direction and guidance for respective clinical studies A data driven approach to planning, executing, and problem solving Effective communication skills via verbal, written and presentation abilities Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization Ability to influence and negotiate across key stakeholders Budget management experience An awareness of relevant industry trends Ability to build productive study teams and collaborations Demonstrated vendor management experience Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC Experience in global clinical trial operations including experience developing protocols and key study documents Knowledge of ICH/GCP and regulatory guidelines/directives Effective project management skills, cross-functional team leadership and organizational skills In order to be considered qualified for this role, a minimum of a Bachelor's degree is required and 6+ years of direct clinical trial experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents. Prior direct sponsor experience is highly preferred. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $126,700.00 - $206,900.00

This role is an onsite position in one of our office locations. Fully remote is not eligible. The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study Provides operational input into protocol development Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensures compliance with the clinical trial registry requirements Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors Provides input into baseline budget development and management Provides input into baseline timeline development and management Leads risk assessment and identifies risk mitigation strategies at the study level Leads the feasibility assessment to select relevant regions and countries for the study Oversees/conducts site evaluation and selection Leads investigator meeting preparation and execution Monitors progress for site activation and monitoring visits and acts on any deviations from plan Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Monitors data entry and query resolution and acts on any deviations from agreed metrics Ensures accurate budget management and scope changes for internal and external studies Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues Oversees the execution of the clinical study against planned timelines, deliverables and budget Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work Ensure clinical project audit and inspection readiness through the study lifecycle Supports internal audit and external inspection activities and contributes to CAPAs as required Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability Contributes to clinical study report writing and review Facilitates and contributes to study level lessons learned Assigns tasks to Clinical Study Management staff and supports their deliverables Recommends and participates in cross-functional and departmental process improvement initiatives Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight May require 25% travel This role may be for you if you have: Exceptional interpersonal & leadership skills Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving Advanced communication skills via verbal, written and presentation abilities Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization Ability to influence and negotiate across a wide range of stakeholders Strong budget management experience An awareness of relevant industry trends Ability to build, lead and develop productive study teams and collaborations Applies advanced negotiation and interpersonal skills to vendor management Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents Knowledge of ICH/GCP and regulatory guidelines/directives Advanced project management skills, cross-functional team leadership and organizational skills Line management experience In order to be considered qualified for this role, you must possess a Bachelors' degree with a minimum of 8 years of relevant clinical trial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $148,300.00 - $241,900.00

This role is an onsite position in one of our office locations. Fully remote is not eligible. The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study Provides operational input into protocol development Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensures compliance with the clinical trial registry requirements Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors Provides input into baseline budget development and management Provides input into baseline timeline development and management Leads risk assessment and identifies risk mitigation strategies at the study level Leads the feasibility assessment to select relevant regions and countries for the study Oversees/conducts site evaluation and selection Leads investigator meeting preparation and execution Monitors progress for site activation and monitoring visits and acts on any deviations from plan Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Monitors data entry and query resolution and acts on any deviations from agreed metrics Ensures accurate budget management and scope changes for internal and external studies Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues Oversees the execution of the clinical study against planned timelines, deliverables and budget Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work Ensure clinical project audit and inspection readiness through the study lifecycle Supports internal audit and external inspection activities and contributes to CAPAs as required Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability Contributes to clinical study report writing and review Facilitates and contributes to study level lessons learned Assigns tasks to Clinical Study Management staff and supports their deliverables Recommends and participates in cross-functional and departmental process improvement initiatives Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight May require 25% travel This role may be for you if you have: Exceptional interpersonal & leadership skills Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving Advanced communication skills via verbal, written and presentation abilities Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization Ability to influence and negotiate across a wide range of stakeholders Strong budget management experience An awareness of relevant industry trends Ability to build, lead and develop productive study teams and collaborations Applies advanced negotiation and interpersonal skills to vendor management Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents Knowledge of ICH/GCP and regulatory guidelines/directives Advanced project management skills, cross-functional team leadership and organizational skills Line management experience In order to be considered qualified for this role, you must possess a Bachelors' degree with a minimum of 8 years of relevant clinical trial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $148,300.00 - $241,900.00

Job Title: Study Feasibility and Activation Manager Department: RCSI Clinical Research Centre, Beaumont Reporting to: Professor Ger Curley, Director of Clinical Research Centre Location: RCSI Smurfit Building, Beaumont Hospital Contract/Duration: 0.4 FTE - Specified Purpose contract up to 17 months Remuneration: Up to €25,000 per annum Closing Date: 28th August 2025 RCSI is a community of academic, research, clinical and professional staff working collaboratively to lead the world to better health. Here, you will thrive in an innovative and inclusive atmosphere and your personal development and wellbeing will be supported. We invite you to join us to help deliver on our exciting mission "To educate, nurture and discover for the benefit of human health". We seek candidates whose experience to date has prepared them to contribute to our commitment to the "Race Equality Action Plan 2025-2029" at RCSI. Our students come from all walks of life and so do we. We hire great people from a wide variety of backgrounds. This makes our university stronger and ensures we hire the best talent. Innovating for a Healthier Future 2023-2027 is RCSI's new five-year strategic plan. Through it, RCSI will enhance human health by meeting the health workforce needs of society, creating the insights and inventions that drive health improvements, and working in partnership with patients and the public in support of better health and well-being for all. The strategy unites the RCSI community in supporting the UN Sustainable Development Goals - with a particular focus on Goal 3, which targets good health and well-being. For each of the last six years, RCSI has been positioned in the Top 300 of universities worldwide in the Times Higher World University Rankings. We are proud that RCSI ranks fifth in the world for "Good Health and Well-being" in the Times Higher Education #SDG #SDG Impact Rankings 2024. This reflects our commitment to supporting people of all ages to live healthy lives and our work to promote the concepts of well-being and positive health. In 2024, RCSI was delighted to be named one of the Sunday Times Best Places to Work in Ireland. At RCSI, our core values of Respect, Collaboration, Scholarship, and Innovation are at the heart of everything we do. We are committed to creating an inclusive and supportive environment where every colleague is valued and empowered to thrive. Our dedication to these values ensures that we foster a culture of mutual respect, open collaboration, continuous learning, and innovative thinking. Join us at RCSI, where your contributions will be recognised, and you will be part of a dynamic team making a real impact on global health. The Royal College of Surgeons in Ireland (RCSI) is a research intensive, world-leading international University exclusively focused on improving human health. The RCSI Clinical Research Centre (RCSI-CRC) was established in 2000 at Beaumont Hospital as the first purpose-built CRC in Ireland. Today, RCSI-CRC supports research in core clinical areas in Beaumont and Rotunda Hospitals, which serve as hubs for seven hospitals in RCSI Hospitals Group, including: 1. Respiratory and Critical Care Medicine - National Centre for Cystic Fibrosis, Alpha-1-Antitrypsin Deficiency. 2. Kidney disease - National Centre for Renal Transplantation, Renal Replacement Therapy, Rare Kidney Disease. 3. Clinical Neurosciences - National Neurosurgical Centre, National Pituitary Centre, National Lead for ENDO-ERN, Stroke/National Thrombectomy Service, National Epilepsy Surgery Service, Motor Neuron Disease 4. Gastroenterology - Centre for Inflammatory Bowel Disease and Advanced Endoscopy. 5. Maternal and Fetal Medicine - Host for HRB Mother and Baby Clinical Trials Network. 6. Haematology and Oncology - Regional/National centre for Breast Cancer, Primary Brain Tumours, Gastrointestinal Tumours, Myeloma/Lymphoma. The development of RCSI-CRC underpins the RCSI and Beaumont/Rotunda Hospital's tripartite ambition to educate, nurture and discover for the benefit of human health. The development of RCSI-CRC will build capacity and capability to deliver clinical trials in our core clinical areas, increase our research outputs and our recruitment to clinical trials. RCSI Clinical Research Centre (RCSI-CRC) Study Feasibility and Activation Manager RCSI-CRC works to improve patient access to clinical trials. We are seeking an exceptional individual to take on the role of CRC Study Feasibility and Activation Manager to deliver the study feasibility and Start-up programme at RCSI-CRC. Specifically, the duties of the post are: o The RCSI-CRC Study Feasibility and Activation Manager will be leading and rapidly conducting the site feasibility, hospital approval process and set-up phase of clinical trials in the CRC. o Guide the sponsor through the sites start up process to ensure a focused approach to timely study activation. This includes receiving a request, disseminating the study information to potential investigators, collating signed CDAs and study feasibility responses from investigators and engaging the ORI Pre-award Team and Industry Engagement supports in relation to same o Manage the feasibility assessment of the study and sites capacity, coordinate the legal agreement process and budget process, processing of the study application through the CRC and the hospitals approval process, liaise with the clinical team on their requirements to conduct the study and coordinate the activation of the study at the site o Coordinate and host feasibility meetings with sponsors and the relevant clinical team members until study greenlight o Review study protocols to determine the requirements for implementation of the study at the site. This includes hospital services, diagnostics, medication and equipment required by site or provided by the sponsor. o Liaise with relevant hospital departments for the provision of services or equipment for the study as required. o Liaise with sponsor on the provision of equipment they are providing for the study. o Gather and collate study start up documentation in preparation for study greenlight and activation such as CV's, GCP certs and training records etc. o Support the PI and the clinical team in the completion of documentation required for the feasibility and activation process, such as feasibility questionnaires, NREC site forms, CRC application form and sponsor forms. o Keep in regular contact with the PI and clinical team on the progress of study start up to prepare for timely activation and recruitment. o Track study activation timelines from first knowledge of the study in the CRC to green light activation. o Provide feasibility and activation metrics to the CRC management team as required. o Be responsible for collating and submitting the documentation required for hospital approval and follow hospitals approval process for study approval. o Inform study team and sponsor when hospital approval has been granted, and provide RCSI and the sponsor with copies of the signed documentation. o Act as the central point of communication about the study until activation o Act as a communication hub for clinical trials in RCSI-CRC. o Develop a local communication plan so that Beaumont Hospital consultants are aware of the RCSI CRC Feasibility Program at induction, research events and workshops. o Develop a database of research interested and/or active investigators in RCSI and Beaumont Hospital o Deliver local support and expertise on how to complete timely study feasibility assessments and study budget preparations. o Support nursing staff in study activation procedures and ensure timely activation of the site when requested by sponsor. o Use CRF Manager software to collate uniform data on Clinical Trials in RCSI-CRC o Keep records of studies worked on and feasibility and activation hours for the purposes of reporting o Work with a wide range of stakeholders and partners including research participants, healthcare professionals, the life sciences industry, academic and research supporting organisations. o The RCSI-CRC Study Feasibility and Activation Manager is expected to enhance clinical trial activity in RCSI-CRC through all of the following core activities: Signposting Promotion Reporting trial activity Streamlining feasibility process, where possible Qualifications: o Degree in a relevant field, for example, Nursing o Good Clinical Practice qualification is required Knowledge & Experience - (Essential): o Three years as a clinical research nurse or other relevant degree with 3 years previous experience and involvement in the conduct of clinical trials. o Be able to demonstrate knowledge of the potential steps in the feasibility process for research studies. o Be able to demonstrate experience in reviewing and understanding the requirements of a clinical trial protocol. o Experience of supporting project plans and implementing them within agreed timelines. o Strong stakeholder management skills with a keen ability to positively influence and negotiate successful outcomes. o Strong ability to effectively manage multiple deliverables simultaneously. o Experience of generating and analysing key metrics to produce and deliver quality information reports for diverse stakeholders. o Experience of motivating high performing stakeholders and fostering a collaborative and supportive culture. o Excellent communication skills with an ability to translate needs and guidance to both clinical and non-clinical stakeholders. o Strong IT and data management skills. Knowledge & Experience (Desirable): o An understanding of GDPR. o Knowledge of hospital approvals process for clinical research. o Knowledge of legislative requirements for clinical research in Ireland. o Knowledge of research governance. "We are all too aware that imposter syndrome and the confidence gap can sometimes stop fantastic candidates putting themselves forward, so please do submit an application - we'd love to hear from you". Application Process Please apply online no later than 5pm on the closing date with your CV and Covering Letter. Informal Enquiries can be directed to Dr Fionnuala Keane, Director of Operations, Clinical Research Centre at . Click here to read our Recruitment and Selection Policy for Researcher.

The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role is not eligible fully remote. This role requires 4-days onsite in one of our US locations. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study Provides operational input into protocol development Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensures compliance with the clinical trial registry requirements Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors Provides input into baseline budget development and management Provides input into baseline timeline development and management Leads risk assessment and identifies risk mitigation strategies at the study level Leads the feasibility assessment to select relevant regions and countries for the study Oversees/conducts site evaluation and selection Leads investigator meeting preparation and execution Monitors progress for site activation and monitoring visits and acts on any deviations from plan Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Monitors data entry and query resolution and acts on any deviations from agreed metrics Ensures accurate budget management and scope changes for internal and external studies Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues Oversees the execution of the clinical study against planned timelines, deliverables and budget Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work Ensure clinical project audit and inspection readiness through the study lifecycle Supports internal audit and external inspection activities and contributes to CAPAs as required Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability Contributes to clinical study report writing and review Facilitates and contributes to study level lessons learned Assigns tasks to Clinical Study Management staff and supports their deliverables Recommends and participates in cross-functional and departmental process improvement initiatives Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight May require 25% travel This role may be for you if you have: Exceptional interpersonal & leadership skills Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving Advanced communication skills via verbal, written and presentation abilities Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization Ability to influence and negotiate across a wide range of stakeholders Strong budget management experience An awareness of relevant industry trends Ability to build, lead and develop productive study teams and collaborations Applies advanced negotiation and interpersonal skills to vendor management Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents Knowledge of ICH/GCP and regulatory guidelines/directives Advanced project management skills, cross-functional team leadership and organizational skills Line management experience In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $148,300.00 - $241,900.00

**Company Description**
**Work with Us. Change the World.**
At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world's most complex challenges and build legacies for future generations.
There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world.
We're one global team driven by our common purpose to deliver a better world. Join us.
**Job Description**
**_Start here. Grow here._**
At AECOM we are currently recruiting for a Project Manager to join us at our Dublin office.
_Here's what you'll do:_
Your day to day will include but not be limited to the following tasks and responsibilities:
+ The role will cover the whole project lifecycle from initial inception, through the design and procurement process and onto the site delivery and commissioning phase.
+ Work with other member of the project management team to successfully manage and deliver capital investment projects.
+ Act as the key day to day client interface ensuring that client objectives are met.
+ Lead project management commissions taking overall responsibility for their successful delivery
+ Planning, directing and supervising all operations included in moderately sized projects with moderate risk, complexity and financial impact
+ Contribute to the overall operational running of the AECOM project management team
+ Recent experience in project delivery of RIBA Stages 0 to 7 is required.
**Qualifications**
**Ready to push the limits of what's possible?**
_Here's what we're looking for:_
As the successful candidate you will have experience working within our construction markets along with having the following qualfications and experience.
+ Post Graduate Qualification - ideally Project Management / Construction / Engineering / Quantity Surveying related
+ In the process of pursuing Chartered Status with either of the following institutions; SCSI/RICS / CIOB / RIBA / EI
+ APM affiliation is a benefit
**Additional Information**
**About AECOM**
AECOM is the world's trusted infrastructure consulting firm, delivering professional services throughout the project lifecycle - from advisory, planning, design and engineering to program and construction management. On projects spanning transportation, buildings, water, new energy and the environment, our public- and private-sector clients trust us to solve their most complex challenges. Our teams are driven by a common purpose to deliver a better world through our unrivaled technical and digital expertise, a culture of equity, diversity and inclusion, and a commitment to environmental, social and governance priorities. AECOM is a Fortune 500 firm and its Professional Services business had revenue of $14.4 billion in fiscal year 2023. See how we are delivering sustainable legacies for generations to come at aecom.com and @AECOM.
**Freedom to Grow in a World of Opportunity**
You will have the flexibility you need to do your best work with hybrid work options. Whether you're working from an AECOM office, remote location or at a client site, you will be working in a dynamic environment where your integrity, entrepreneurial spirit and pioneering mindset are championed.
You will help us foster a safe and respectful workplace, where we invite everyone to bring their whole selves to work using their unique talents, backgrounds and expertise to create transformational outcomes for our clients.
AECOM provides a wide array of compensation, benefits and well-being programs to meet the diverse needs of our employees and their families. We're the world's trusted global infrastructure firm, and we're in this together - your growth and success are ours too.
Join us, and you'll get all the benefits of being a part of a global, publicly traded firm - access to industry-leading technology and thinking and transformational work with big impact and work flexibility. As an Equal Opportunity Employer, we believe in each person's potential, and we'll help you reach yours.
We are a Disability Confident Employer and will offer an interview to applicants who have a disability or long-term condition, who meet the minimum/essential criteria for the role. Please let us know using this email address if you would like to apply through the Disability Confident Interview Scheme.
All your information will be kept confidential according to EEO guidelines.
**ReqID:** J10133278
**Business Line:** B&P - Buildings & Places
**Business Group:** DCS
**Strategic Business Unit:** Europe & India
**Career Area:** Program & Project Management
**Work Location Model:** Hybrid
**Legal Entity:** AECOM Ireland Limited

**23 months FTC**
**Position Summary**
Under the general direction of an Engineering Manager PMO is responsible for the leadership and directing of moderate complexity projects, which may require considerable Resources. Responsibility for all aspects of the project from initiation to completion. Interfaces with all Stakeholders affected by the project including end users. They direct a multi-disciplinary team to complete a project and achieve the project's objectives. This is an onsite role.
**What you will do:**
+ Lead medium sized projects through PMO.
+ Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
+ Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
+ Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
+ Ensure a common understanding by setting expectations in accordance with the Project Plan, to align the stakeholders and team members.
+ Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
+ Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorised changes to facilitate customer acceptance.
+ Responsible to improve team performance by building team cohesiveness, leading, influencing, and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
+ Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
+ Must be able to analyse and correct complex process and/or system issues of a broad scope using independent judgment.
+ Interface with Materials Science, Design and Quality Assurance departments to provide customer with a quality product in a timely manner. Understands quality system(s).
+ All other duties as assigned.
**What you will need:**
+ Level 8 Degree in Mechanical Engineering or relevant discipline or equivalent experience is required.
+ Proven Project Management skills through the delivery of business-critical projects in excess of $0.5M which have been delivered on time and in Budget.
+ Has minimum of 5 years demonstrated project management experience preferably in a manufacturing environment.
+ Ability to oversee technical advancements.
+ Ability to generate and explain detailed proposals, schedules, objectives, and other documentation accurately and Confidently present Project updates to SLT.
+ Utilise software to maintain project records, such as a PM system, MS Office, MS Project, SharePoint, or Visio
+ PMP certification or equivalent is a plus.
+ Excellent interpersonal communication, influencing, collaborative teamwork and negotiation skills with ability to integrate a team.
+ Ability to build trusting relationships with mid-level management.
+ Demonstrated experience in presenting to executives.
+ Capable of working as part of a multi-disciplined team in an aggressive, dynamic, flexible and results motivated environment.
+ Demonstrated ability to work without supervision.
+ Manages project challenges with discipline and maintains control of stressful situations.
+ Pursues goals to completion when faced with demanding timelines.
+ Confident and effective decision maker who engages stakeholders in productive conversation regarding feedback
#IJ
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Company description: FBD Holdings PLC Job description: The Project Manager will report to the Programme Lead regarding the delivery of one the programmes individual projects. Working with senior colleagues from IT, Underwriting, Sales and Finance, the PM will own the end-to-end responsibility for delivery of the assigned project. This role is concerned with pragmatic collaboration with stakeholders, colleagues and vendors to manage all of the assigned projects deliverables in terms of time, cost, quality, scope and risk. Job Responsibilities Project manage a multi disciplinary team comprising of a range of technical skills such as Solution Architecture, Business subject matter expertise, Product Design, Software Engineering, Business Analysis, System Integration Testing, User Acceptance Testing, Business Readiness, Release & Environment Management; Develop, obtain approval for and manage the projects budget; Define resource requirements to achieve the projects objectives; Develop the project charter and manage all aspects of project governance; Develop the project plan, identify and sequence activities and produce the project's work breakdown structure; Plan and design the project and proactively monitor and control its overall progress against the delivery schedule; Provide timely and accurate status reports regarding progress of the project at Steering meetings; Manage risks and issues that may impact the project to ensure they are controlled effectively and understood by stakeholders, developing innovative solutions and initiating corrective action as appropriate so as to resolve matters; Manage communications with stakeholders, third parties and internally within the project delivery team; Manage co-ordination and inter-dependencies with other projects; Manage outsouced provider(s) to deliver to the projects expectations; Establish the projects quality assurance processes. Initiate activities and manage intervention where gaps in the project are identified or issues arise; Provide leadership and direction to work streams including Technical Analysis, Application Development, Infrastructure and QA Testing; Work with the Business and technical experts to define business requirements and pragmatic solutions; Plan and manage acceptance into service of the projects implementations into the production environment. Education Third Level Qualification in Computer Science / IT. Project Management Certification e.g. PMP, CAPM, PRINCE 2. MS Project and MS Office toolset (Word, Excel, PowerPoint). Experiences A minimum of 7 years of project management experience running large scale legacy transformation programmes. Experience in the full breadth of project management processes. Experience of general insurance, life assurance or financial services environments would be preferable. Experience of migrating from legacy systems in a financial services marketplace would be a distinct advantage. Experience of Agile/SCRUM methodologies would be helpful, though not a prerequisite. Competencies Knowledge of process improvement methodologies (ie 6-Sigma) an advantage. Delivery focused with a strong aptitude for team motivation. Highly organised and structured approach to working. Excellent facilitation and communication skills, both written & verbal. Strong leadership and coaching skills. Ability to interact effectively with both technical and business personnel. Ability to activitely get invloved in every phase of the project and pitch in if required. This role sits within Pay Band E of FBDs IT Function Pay band. FBD is an inclusive Equal Opportunity employer that considers applicants irrespective of their age, gender, ethnicity, culture, religion, language, sexual orientation, ability, disability and social circumstances. Skills: Project Management PMP CAPM PRINCE 2 Benefits: Bonus Canteen Lunch Vouchers Paid Holidays Parking Pension Staff discount