Description
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.
This is a 1 year contract position; with further extensions in place.
Responsibilities:
- In compliance with regulations you will execute trials according to plans and timeline, commitments in alignment with strategy to achieve global and regional objectives.
- Communicates planned milestones to Trial Monitoring stakeholders and update on operational activities at the Region/Country level, during the course of the trials to meet 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
- Actively participates in the development of reporting methodologies, and implements performance reporting for trial monitoring, ensures accurate and complete operational data within corporate systems.
- 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)
- 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; assessing impacts, developing risk management plans and communicating/escalating to appropriate stakeholder
Requirements
- 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
- Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities regulations.
Please contact luchele Mendes on
Michael Bailey International is acting as an Employment Business in relation to this vacancy.