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Job Title:
Clinical Operations Manager

Location:
Remote (with some travel required)

Reports to:
Operations Manager

The Clinical Research Platform (CRP) is an Irish Site Management Organisation (SMO) and enabler of research and clinical trials. We enable Clinicians to become involved in clinical research opportunities for some of the world's leading pharmaceutical and biotechnology companies.

We are committed to providing our expertise in clinical trials and site management to ensure the best quality and care in executing clinical research here in Ireland.

Job Purpose

The Clinical Operations Manager will assist in overseeing and supporting the delivery of clinical trials across the CRP network of sites. The role ensures studies are conducted to the highest standards of quality, regulatory compliance, and patient safety, while supporting investigators and site staff to meet recruitment and retention goals. The Clinical Operations Manager will also contribute to strengthening clinical research education within the team and improving organisational efficiency.

Key Responsibilities

• Lead the day-to-day management of education and clinical support across sites.
• Oversee education and training for new staff.
• Assist in the implementation of recruitment strategies for each study.
• Support, advise on and oversee clinical aspects of research studies, in accordance with study protocols and relevant regulations.
• Manage and support research nurses, coordinators, and study teams to ensure adherence to protocol, GCP, and local regulatory requirements.
• Support site teams in maintaining inspection and audit readiness.
• Ensure all clinical operational documentation (SOPs, study logs, site files) is accurate, complete, and audit-ready.
• Collaborate with Quality and Regulatory team to ensure compliance with GCP, GDPR, and international standards.
• Drive performance monitoring, including recruitment targets, KPIs, and operational metrics.
• Support staff training, development, and performance reviews.
• Contribute to strategic planning for the growth of the organisation's clinical research portfolio.
• Maintain effective communication with staff to ensure information is transferred in a clear effective manner.

Qualifications & Experience

• Registration as a health care professional (e.g. registration in the General Division of the Nursing register kept by An Bord Altranais)
• Bachelor's degree in life sciences, nursing, or a related field.
• Minimum 5+ years' experience in clinical research, with at least 2 years in a management or leadership role.
• Strong understanding of ICH-GCP and regulatory processes.
• Proven track record of successfully managing multi-site trials.
• Excellent leadership, communication, and organisational skills.
• Ability to work collaboratively across clinical and operational functions.

Key Competencies

• Leadership and team development
• Strategic and operational planning
• Problem-solving and decision-making
• Strong interpersonal and negotiation skills
• Results-driven with attention to detail
• Adaptability in a fast-paced research environment

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POSITION SUMMARY:

Oversees the clinical feasibility assessment and strategic planning of clinical trial programs or studies. Executes on these global programs or studies in one or more assigned therapeutic area(s) from decision to start a clinical development up to the market authorization. Manages budgets, timelines and quality of deliverables for assigned program(s) and study(ies) in accordance with International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, applicable regulatory requirements, company standard operating procedures (SOPs), and study protocols.

KEY RESPONSIBILITIES:

• Oversees integrity of clinical data to ensure data meets GCP standards.
• Maintains good knowledge of the literature for the indication being studied and reviews and summarizes all published literature for the therapeutic area of interest.
• Participates in cross functional project teams and presents program information to internal and external audiences.

Investigator Sponsored Research Proposals:

• Provides clinical review/input to Investigator Sponsored Research proposals.

Clinical Development Strategy/Input:

• Assesses best strategic path forward for a clinical program and drives clinical strategy recommendations including timelines and cost to key stakeholders.
• Orchestrates expert meetings to elucidate the best clinical path forward for a clinical program.
• Identifies risks, mitigations, opportunities and contingency plans for assigned program(s) and study(ies).
• Escalates significant issues on program(s) and study(ies) to senior management in a timely manner.

Project Management Office /pCTSR:

• Drafts clinical components from decision to start a clinical development and up to the market authorization (DP1-DP5) gates, liaise cross-functionally to provide clinical input on all development stages and Target Product Profile, as necessary.
• Provides clinical status updates to the Project Management Office (PMO) and to the Upper Management.

Team Management/Trainings:

• Manages direct reports through performance evaluations and addressing professional development.
• Ensures compliance of each Clinical Development trial team with the trial-specific training requirements
• Participates and contributes to internal and external training for clinical program (e.g. Kick-off meeting, Investigator's meeting)

Vendor Management:

• Manages clinical timelines, budgets, and resources against the approved clinical development plan (CDP) in collaboration with contract manager.
• Participates in development of vendor specifications to ensure accurate interpretation of the protocol requirements (e.g. processes and data collection) and contributes to the vendor selection.
• Supports the Program Manager in overseeing third party vendors performance (e.g., contract research organizations (CROs), central labs) including on time study completion, budget adherence, and quality deliverables. In particular it may include the review of monitoring reports, approval of clinical plans, regular review of protocol deviations and activities related to the oversight of the trial master file (TMF) status, completed together with other clinical operations team members.
• Contributes to the evaluation of the vendor performance to ensure early mitigation/resolution of potential issues and develops/implements corrective action plans as appropriate, along with the Program Manager
• Performs Sponsor Site Visits at selected sites to oversee the site and the monitoring performances, to increase the communication with the site and awareness of protocol burdens. Documentation of the Sponsor Visits and follow-up of appropriate corrective and preventive actions.

Clinical Trial Design/Performance:

• Provides clinical review/input to clinical documents (e.g., protocols, investigator brochures, periodic safety reports and clinical study reports) and ensures the accuracy and integrity of clinical data prior to submission to regulatory authorities (e.g. Investigational New Drug (IND) application, Clinical Trial Application (CTA), Biologics License Application (BLA), Marketing Authorisation Application (MAA))
• Drafts or provides review/input for publications from clinical study data and white paper literature reviews on new products or safety questions.
• Participates in regulatory authority meetings.
• Partners with Biometry to develop the case report form, data management plan and statistical management plan.
• Reviews protocol deviations and data listings to ensure integrity of data and identify trends on ongoing basis.
• Provides oversight and collaboration with Biometry to ensure timely data transfers for data cleaning, review and analysis.
• Offers guidance to resolve escalated study conduct issues and provides clinical responses to questions from study center personnel, regulatory authorities and institutional review boards/ethics committees.

Audits/Inspections/Quality Assurance (QA):

• Oversees responses to vendor/site audits, as necessary.
• Oversees responses to internal audits.
• Contributes to processes improvement.
• Contributes to preparation of site inspections, attends site inspections, and supports responses to site inspections, as necessary
• Manages preparation of internal inspections, attends internal inspections, and manages responses to internal inspections.
• Supervises quality of the clinical trial and ensures implementation of Corrective and Preventive Actions to quality deviations and misconducts.

PERSON SPECIFICATION:

• 10+ years of experience in clinical research, including 2 to 5 years in a study management/leadership role. Advanced verbal, written and interpersonal skills that enable cross-functional issue resolution.
• Advanced strategic thinking abilities for proactive planning and decisive decision making.
• Advanced ability to set and meet deadlines, multitask, and prioritize based on program and/or study needs.
• Advanced ability to facilitate and/or present at departmental, study, project and investigator meetings.
• Strong leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel. Bachelor's degree in relevant discipline
• Typically requires a minimum of 10 years of clinical research experience with at least 6 years clinical trials management / leadership role, including clinical document production, trial execution and involvement in clinical trial feasibility and strategy.
• Master's degree or higher-level degree in relevant discipline. (2-years' experience equivalence for a MD and 4-years' experience for a master's degree).
• Advanced leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel.

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you.

Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3

Learn more about Grifols

Job Description
Applications are invited for the above full-time permanent positions.
The Organisation
Stewarts Care is a long-established voluntary organisation providing comprehensive community-based services to people with intellectual disabilities in West Dublin, North Kildare and Meath. These positions are based in West Dublin and North Kildare.

We support people with a wide range of support needs across residential settings, day services, supported independent living, job advocacy and vocational training.

Purpose Of The Post
As a member of the Resident Services Team, Care Staff work to enhance the lives of Residents. They must work effectively with all staff directly involved with the residents of Stewarts Care.

These roles require flexibility to workdays, evenings, waking nights, sleepovers and weekends.

Candidates must meet the following criteria relevant to the role:

• Minimum QQI Level 5 (Healthcare Support) or SKILL-VEC Level 5 (or working towards).
• A strong desire to work with persons with an intellectual disability.
• The aptitude to provide a person-centred approach to service user programmes.
• Excellent communication skills both verbal and non-verbal.
• Be Flexible to meet the needs of the organisation.
• One years' experience working in the area of disability is preferable.
• Driver's licence is desirable.

General Duties

• To Supervise the residents in all aspects of daily life, have due regard for their safety and the safety of others, both on and off sections including outdoor activities in accordance with Stewarts Care Policy.
• To ensure that all efforts are made to cater for the physical and emotional needs of the residents to ensure the highest quality of care.
• To assist in the day to day running of sections so that each area is run in a manner that is in keeping with the highest professional standards and care.
• To assist in the training of residents and to observe and report on residents to nursing staff and other personnel directly involved with residents when requested. To assist in client assessment and programme implementation.
• To accompany residents to outside clinics, hospitals or other centres where they have been transferred for specialised treatment or care and to give a preliminary verbal report on returning to residence.
• To assist in the implementation of nursing treatment as directed.
• To assist in the induction of new Care Staff to the Residents and general routine.
• To accept delegated responsibility for residents when requested as directed by the Manager/Social Care Worker or Nurse in Charge.
• To attend In-service Training Programme and lectures educating on the development of service users.
• Attend Fire Prevention and Emergency Training Sessions and become conversant with them and to implement fire orders as per letter of appointment.
• Observe strictly the Code of Confidentiality.
• Maintain Hygiene and tidiness in area assigned to.
• Undertake training for the safe administration of medication.
• Administer medication in line with organisational policy.
• I n the course of employment all employees may be required to support residents or day attenders in leisure activities including participating in activities in the swimming pool, cooking, cleaning and driving.

Salary and qualifications are in accordance with Department of Health consolidated pay scales. Salary Scale is
€34,036
-€47,454 incl LSI
per annum .

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.

The Associate Director / Group Head will lead a community of 20 Clinical Data Acquisition Specialists, Clinical Data Scientists and Coding Specialists as assigned to individual therapeutic areas (TA) responsible for ensuring adequate staffing/resource allocation for delivery of the portfolio to the TA area (managing attrition, hiring, talent retention); people management/career development, employee engagement of the community. Facilitate the sharing of resources between groups to meet company goals and objectives.

Furthermore, will partner with Senior Group Head in contributing towards the TA-community's goals and KPIs (quality, cost, cycle-time and productivity). To partner and support the functional mentors within the community to set up learning networks across all communities within Clinical Data Acquisition and Management (CDAM). Work seamlessly with partner group to lead, contribute to and implement initiatives to establish and maintain Novartis CDAM as best in class in the industry

Major accountabilities:

• Selects, recruits, develops, manages, motivates, coaches and appraises the performance of direct reports to ensure high quality performance across their community of Clinical Data Acquisition and Management associates/roles (Clinical Data Scientists, Clinical Data Acquisition Specialists and Coding Specialists)
• Facilitates a partner and customer oriented Clinical Data Acquisition and Management group, role modelling behaviors for the associates within their community as per the Novartis Values and Behaviours.
• Accountable for the assignment of resources and workload within his/her community, and ensures sharing of resources between groups in order to meet company objectives and priorities
• Partners with the functional mentors within own community and Functional Experts within CDAM to ensure associates are empowered and able to take the right decisions to solve issues at the trial/program delivery level.
• Understands Health Authority requirements and is able to participate in Health Authority inspections as required
• Builds and establishes a strong team spirit and creates a team founded on technical ability, excellence in performance and exhibiting the Novartis values and behaviours
• Leads/supports non-clinical special projects and initiatives. Provides subject matter expertise through self/through team to special projects as needed
• Highlight the need for training programs and support the establishment of these (technical and professional skills) for Clinical Data Acquisition Management team members.
• Ensures high quality communication and information flow on status of trials to stakeholders, mitigates and manages risks
• If required deputizes for the Senior Group Head of Clinical Data Acquisition and Management as required
• Maintain external focus by interacting and influencing industry working groups and organizations

Ideal Background

• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
• Proven leadership, collaboration and organizational skills with relevant experience within Clinical Data Management / Clinical Data Science environment
• Excellent understanding of clinical trials methodology, GCP and medical terminology
• Ideally 10 years' experience in Drug Development with at least 6 years' in Clinical Data Management with at least 5 years line management or leadership experience

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

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Division

Development

Business Unit

Innovative Medicines

Location

Ireland

Site

Dublin (NOCC)

Company / Legal Entity

IE02 (FCRS = IE002) Novartis Ireland Ltd

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.