Beschreibung
We are recruiting for a Trial Operations Manager for a global position within a multinational pharmaceutical company. You will be responsible for the oversight and coordination of the global monitoring operational aspects of assigned clinical trials, from start-up to close-out. This role is a great mix of strategic and operational duties where planning, feasibility assessment, trial allocation, start-up activities coordination, patient recruitment, clinical and delivery of data, sites close-out, audit and inspection preparation activities will be some of the main responsibilities.Responsibilities:
- Execute trials according to strategy in-order to achieve global and regional objectives.
- Participate in the development of innovative solutions in clinical trial planning and execution, including country, site and patient engagement to ensure the delivery of assigned studies on time
- Develop planning for prospective management of clinical trials including operational risks for each phase of the trial (Feasibility/allocation, Start-up, Data collection and cleaning) using available internal and external resources (patients' incidence, competitive landscape regional strategies, data, statistical plan)
- Drive conduct of medical and operational feasibilities and communicates aggregated feedback to clinical teams; supports protocol development; evaluates potential risks within the protocol and operational aspects of the study; assessing impacts, developing risk management plans and communicating/escalating, as appropriate
- Is accountable for recruitment activities; responsible for forecasting, setting up contingency planning to ensure recruitment targets are achieved in accordance with trial execution plan.
- Evaluate potential challenges/risks within the protocol and operational aspects of the study in line with the prevailing legislation, GCP, Ethical Committee, and SOP requirements; assessing impacts, developing risk management plans and communicating/escalating to appropriate stakeholder
Requirements:
- Advanced degree, preferably in life sciences
- 3+ years' experience in clinical research, in planning/executing and/or monitoring clinical trials
- Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations
- Demonstrated ability to collaborate across partner functions in a matrix environment, without direct reports, but can coordinate the activities of others
- Project/trial management and/or CRA or CRA management, Clinical Study Managers experience preferred
- Proven ability to manage operational challenges at global, regional or country level for large complex trials with minimal supervision
- Excellent project management capabilities with demonstrated ability to problem solve and mediate complex issues
Please send CVs or call
Michael Bailey International is acting as an Employment Business in relation to this vacancy.