For our client, a leading international pharmaceutical company in Basel, we are looking or a dynamic personality in the function of
Lead Clinical Trial Manager (m/f), 100%, Basel
- You are responsible for the delivery of an agreed trial as defined in the trial outline/protocol and operational plan, to the agreed quality, budget and timelines.
- Lead, coordinate and manage all activities related to clinical trials. In case of deviations from plan, provide options for decision making on what to do.
- Ensure that the mandatory regulatory requirements are in place to comply with country-specific requirements.
- Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility agreement in place with CRO.
- CRO selection process and communication of expectations to be met by the CRO. Give input to and review CRO contract with respect to tasks, budget, timelines.
- Develop sponsor oversight plan and carry out Day to day responsibility of the CROs on the given studies. In case of underperformance of CRO, provide action plan.
- Liaison with clinical trial team members regarding trial design and protocol preparation and ensure the production of the final trial protocol.
- Development of operational plan and risk management plan for the conduct of the clinical trial.
- Communicate timelines, identify milestones, handle trial budget and report progress for the clinical trials
- Specialist area such as eCRF, ePRO, centralized monitoring, sponsor oversight
- University degree within medicine or life sciences
- Extensive experience within clinical drug development
- At least 3 years' experience in managing clinical trials (phase I or phase II/III, as applicable)
- GCP certification
- Experience with multi-country and multi-centre studies
- Fluency in English
- Experience within clinical regulatory affairs is desirable
Start date: asap
Duration: Temporary at first, with the option of becoming a permanent position after a few months
Place of work: Basel
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Insa Voss (+41 61 270 80 07).