5 Clinical Trials jobs in Ireland

Director, Program Operations Leader - Early Phase Clinical Trials

Dublin, Leinster Regeneron Ireland DAC

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For US Locations, this position is on-site 4 days per week and 1 day from home. For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The Dir POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The Dir POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring, and performance management. In a typical day, you will: Be responsible for the overall success of the clinical study team(s) within a program(s) Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development Oversee clinical study timelines within a clinical program(s) Provide input and operational insight into Clinical Study Concepts (CSC) Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). Drives decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation Be 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. To be considered, you must possess: A Bachelor's degree and minimum of 12 years relevant in-house sponsor-side industry experience, 8 years within clinical operations. 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) $0.00 - $0.00
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Sr. Engineer Drug Process Development Inspection

Amgen

Posted 26 days ago

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**What will you do**
The Sr Engineer will drive excellence and innovation in both large and small molecule drug product manufacturing at Amgen Dun Laoghaire. As a key player in our global Process Development organization they will be instrumental in ensuring the highest standards of process performance, while also leading the charge in innovative process improvement strategies.
+ Acts as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in inspection.
+ Drives the establishment of visual inspection objectives, focusing on regulatory expectations and network alignment.
+ Supports make-a-batch exercises to determine facility fit and identify gaps in the Visual Inspection process.
+ Supports New Product Introduction with visual inspection method development and AVI characterization.
+ Supports calculation of defect limit updates for new products and re-evaluation of current products.
+ Provides expertise on defects identified during batch inspection and supports defect library updates.
+ Supports in the development of visual inspection team members.
+ Support in the development of new inspection lines - URS / Vendor Selection
+ Provides support for manufacturing and commercial activities.
+ Assists in process related deviations, exception resolution and root cause analysis to ensure smooth operations & continued supply.
+ Assists in troubleshooting issues with drug product processing technologies and equipment.
+ Establishes strong working relationships with partner sites across DP Manufacturing network to foster the sharing of technical best practices, improvement opportunities and lessons learnt to deliver high-quality manufacturing processes.
**Basic Qualifications**
+ Bachelors degree & 8 years of directly related experience OR
+ Masters degree & 6 years of directly related experience
+ Experience in a regulated and or vision related work environment Preferred
**Preferred Qualifications**
+ 10+ years of drug product process development experience in the pharmaceuticals/biotechnology industry.
+ Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations.
+ Experience in working with vision related systems and validation of inspection equipment.
+ Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
+ Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
+ Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent communication skills are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.
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Clinical Research Nurse - Cardiology (CNM2)

Dublin, Leinster Mater Private Hospital Group

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Be a Heart Research Hero: Clinical Research Nurse (Cardiology) Join our passionate team at the forefront of cardiovascular research! As a Clinical Research Nurse (CNM2) at the Mater Private Hospital's Cardiovascular Research Institute Dublin, you'll play a pivotal role in driving advancements in heart health. Why you'll thrive here: Make a tangible difference in the lives of cardiac patients through groundbreaking research. Collaborate with a dedicated team of researchers and clinicians in a dynamic environment. Gain valuable experience in clinical research methodologies and contribute to impactful publications. Utilise your strong clinical skills and organisational talents to ensure smooth study execution. Responsibilities: Work alongside investigators to recruit participants for clinical trials in cardiology. Manage research databases and ensure accurate data collection. Coordinate patient study visits, adhering to protocols and regulations. Educate and support patients throughout the research process. You're a great fit if you have: A minimum of 5 years' experience as a Registered General Nurse with the NMBI. At least 2 years' experience in cardiology care. Proven clinical and managerial skills with a keen interest in research. Excellent interpersonal and communication abilities to build rapport with patients and colleagues. Strong organisational skills and a meticulous attention to detail. Bonus points for: Prior experience in clinical research. Postgraduate qualifications in research or cardiology. The Mater Private Network offers: Competitive salary and benefits package. Opportunities for professional development and training. A supportive and collaborative work environment. Be part of a team making a real difference in healthcare. Ready to join us? We look forward to receiving your CV! Mater Private Network is an Equal Opportunities Employer Skills: Research Nurse Manager
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Clinical Research Nurse (CNM II)- Cardiology

Dublin, Leinster €44846 - €53151 hour recruitNet

Posted 356 days ago

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Permanent
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.
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Clinical Nurse Manager 1 - Research Nurse

Dublin, Leinster Childrens Health Ireland

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Purpose of the Role Clinical research is essential to provide an evidence base for improved medicines and treatment of sick children. It is well accepted internationally that hospitals active in research and innovation are associated with better outcomes for patients and better recruitment and retention of staff. As Ireland's largest paediatric hospital and the leading centre in Ireland for the conduct of clinical trials and studies in children and young adults, CHI has placed excellence in research and innovation as one of its key strategic objectives. As part of ongoing development at CHI towards the opening of the new Children's Hospital, a rationalisation and integration of the existing clinical research infrastructure across all sites is being undertaken. Under the leadership of the CHI Director of Research & Innovation, a new Research & Innovation Office (RIO) and Clinical Research Centre (CRC) are being set-up within CHI and will bring all aspects of clinical research infrastructure together under a single governance and management structure. The Clinical Research Centre is the forerunner of the new paediatric Clinical Research Facility (CRF) that will be embedded in the new Children's Hospital. The CRC is made up of a team of research staff working across CHI sites to support clinical teams in the conduct of clinical trials and other clinical research studies that require specialist expertise and support. The Clinical Research Nurse is a key part of this team, working to support Investigators and research teams with clinical research activities. They will act as the primary advocate for the patient, both prior to and throughout their participation in a research study or clinical trial. As part of a team of Research Nurses, they will work closely with the CRC Operations Manager, Project Managers, Research Nurses and Research Coordinators, ensuring that study activities are carried out effectively and in compliance with Good Clinical Practice (GCP) standards. They will have particular focus on assisting the Principal Investigator to enrol patients to studies and clinical trials and schedule and conduct study visits, ensuring patient safety throughout and maintaining the Investigator Site File. Throughout the research study lifecycle, this role will provide continuity back-up and support as required to other Clinical Research Nurses and Coordinators to ensure the smooth running of research activities from set-up through to closeout, across the portfolio. This is an exciting opportunity to work within a highly motivated team and a dynamic environment, and to be involved in bringing advancements in health outcomes for children and young adults in Ireland. The role offers opportunities for ongoing professional development and the successful candidate will be provided with training and mentoring specific to their role. Essential Criteria: Be registered in the Children's division of the active register of Nurses & Midwives maintained by the Nursing and Midwifery Board of Ireland (Bord Altranais agus Cnimhseachais na hireann) OR Be registered in the General Division of the active register held by NMBI and have relevant children's nursing experience AND At least 3 years post registration experience or equivalent relevant experience. Have the clinical, managerial and administrative capacity to properly discharge the functions of the role Demonstrate evidence of continuing professional development at the appropriate level To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
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