Clinical Project Manager
Posted on Apr 27, 2020 by Michael Bailey Associates - Zurich
We have a need for experienced clinical operations Leader, with prior experience in managing clinical studies in ph IV. This is a contract position for a year with possible extension.
Support clinical operations activities such as vendors management, performance KPI and project deliverables,
Perform Data Review and coordinate the cross-functional data review team.
Directs the operational execution of clinical study activities in accordance with company SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to ensure overall data quality, integrity, and patient protection.
Manages planning, tracking and forecasting of the Global Clinical Operations budget and timelines for the study against the agreed goals.
Develops and maintains budgets for study(s) that include short and long range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals.
Manages CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and achievement of study milestones within agreed upon timelines and budget. Communicates clinical studies performance data to other members of the management and scientific team.
Prepare and maintain required study and regulatory documentation, eg:, reports for Competent Authority submissions, master patient informed consent, Monitoring Plan, Pharmacy Manual, Investigator Agreements and budgets. Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report
Solid experience in managing clinical trials including prior experience in post marketing and observational studies.
Only Swiss based candidates will be considered due to the current situation.
The position is reqjuried to be based in Zurich - some flexibility to work from home is offered
Michael Bailey International is acting as an Employment Business in relation to this vacancy.