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.
* Execute trials according to strategy inorder to achieve global and regional objectives.
* Participates 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
* Develops 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)
* Drives 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.
* Evaluates 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
* Advanced degree, preferably in life sciences
* Fluent English (oral and written)
* 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
* Understand and apply medical and business knowledge to clinical trial execution
* Excellent negotiation and conflict resolution skills
Please send CVs or call +41 (0) 44 215 2051
Michael Bailey International is acting as an Employment Business in relation to this vacancy.