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 long term contract opportunity.
Main Selection criteria: Experience in Feasibility, Recruitment for challenging studies, Project Management, Global experience including knowledge of regulations in different countries, Clinical Trial experience.
Responsibilities:
- Execute trials according to plans and timeline, commitments in alignment with Trial Monitoring strategy and on behalf of the Trial Monitoring organization to achieve global and regional objectives.
- Communicate planned milestones to Trial Monitoring stakeholders and update on operational activities at the Region/Country level, during the course of the trials to meet.
- 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 - Actively participate in the development of reporting methodologies, and implement performance reporting for trial monitoring, ensuring accurate and complete operational
data within corporate systems. - Is responsible to have trials execution according to enrolment commitment and timelines.
- 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 communicate aggregated feedback to clinical teams; support protocol development; evaluate 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.
Requirements
o Advanced degree, preferably in life sciences
o Fluent English (oral and written)
o 3+ years' experience in clinical research, in planning/executing and/or monitoring clinical trials
o Demonstrated ability to collaborate across partner functions in a matrix environment, without direct reports, but can coordinate the activities of others
o Project/trial management and/or CRA or CRA management, Clinical Study Managers experience preferred
Please send CVs or call
Michael Bailey International is acting as an Employment Business in relation to this vacancy.