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Clinical Project Manager Career Profile
Clinical Project Manager
The clinical project manager, in conjunction with leading local and global investigators, functions to ensure effective and efficient management and support of clinical research studies from an administrative perspective, in accordance with ICH-GCP, Research Governance Framework and IMB regulations.
The Clinical Project Manager will have a leading role in planning, coordinating and completing specialised clinical research projects. They will need excellent communication, presentation skills and the ability to organise both themselves and others. They will be responsible for the day-to-day management of clinical research studies and will work closely with the Principal Investigators to ensure their successful completion.
Key Responsibilities
- Communicate effectively with health care professionals, researchers, administrative staff and users of the health service both nationally and internationally.
- Motivate and maintain a collaborative group, including groups across multiple jurisdictions (UK and Ireland).
- Produce regular reports and progress reports appropriate for collaborators, Steering Groups and Monitoring and Ethics Committees as appropriate.
- Plan contact with collaborators whether that be with individuals, groups or the whole group and monitor effectiveness of that contact.
- Liaise with national and international Ethics Committees as required.
- Liaise with funding bodies, the host institution and any other relevant institutions.
- Ensure all trial procedures are developed according to the relevant Good Clinical Practice and Data Protection Guidelines.
- Monitor, in conjunction with the relevant PIs, adverse events and ensure appropriate action.
- Where appropriate, assist with publishing in relevant scientific journals throughout duration of study.
- Employ standard project management techniques to achieve the project goals and objectives in a timely fashion
- Monitor budget and report back to allow efficient and accurate budget management
- Recruit, train, appraise and supervise members of trial team and work with them to ensure successful completion of the project.
- In conjunction with the PIs, design, produce and regularly update all trial materials.
- Carry out projects with a view to establishing a library of general SOPs required for clinical research.
- Contribute to the management and effectiveness of the Institute as a member of its Management Team.
- Network with other Clinical Research Networks in Dublin and across Ireland.
Qualifications & Experience
- Minimum of 4-5 years experience of coordinating and/or managing clinical trials or similar health related projects (e.g. CRA, CPM)
- Degree or Masters level qualification in a relevant scientific/healthcare field
- Knowledge of PRINCE 2 or similar Project Management Methodology
- Knowledge of MS Project or similar software tools for project planning and monitoring
- Knowledge of relational databases and data management an advantage