Post-Registration Clinical Trial Manager (home-based Europe)
For one of our clients, a well-established organization focusing on developing innovative medicines for improving people’s health and quality of life through a public-private partnership model, we are currently looking for an enthusiastic Post-Registration Clinical Trial Manager for a 12-months contract. The company is based in Geneva, but working from home is also an option for employees in the EU.
As an ideal candidate you should have 7+ years of experience in Clinical Trial management of Phase IV observational studies in emerging markets, and ability to provide strategic input to senior management.
As an Post-Registration Clinical Trial Manager you will provide consultancy services for non-interventional and low-interventional (phase 4) studies to the molecule’s proposition protocols with respect to oversight of Sponsor operational responsibilities for the feasibility studies in Brazil and Thailand, possibly extending to India, Ethiopia and Laos.
- Participation in team calls including Pharma partner, CRO and site representatives, plus any third parties as indicated. Provide updates as required to the Director Clinical Operations, Access and Product Management (APM) Project Director (PD), and Medical Director on progress and issues;
- Identify, develop and ensure delivery of study management plans appropriate to the phase of study and observational/low-interventional nature of the study;
- Provide strategic input in the overall development of the protocols (identify potential gaps, support the development of budget and timeline to start the study in time, support the development of the data management plan, clarify roles and responsibility if needed etc.);
- Review/develop SOPs in the context of a non-interventional or low-interventional (as appropriate) study framework;
- Oversight of site start up activities, execution of the study and closure according to approved timelines, protocol and budget;
- Lead the Clinical study team and ensure duties and functions are appropriately delegated and documented;
- Ensure the TMF is set up and maintained with timely complete filing throughout all stages of the Clinical study.
Qualifications and Experience:
- Degree in Life Sciences;
- 5-7 years of work experience in Global Clinical Trial Management, particularly in post-authorisation studies in emerging markets;
- Experience living and/or working in developing countries would be a strong asset;
- Experience within cross-functional development teams, resulting in broad understanding of the multi-disciplinary aspects of drug development;
- Strong problem-solving skills and analytical capabilities;
- Detail-oriented with strong organization skills;
- Fluent in English essential, German or French advantageous;
- Relevant working/residency permit or Swiss/EU-Citizenship required.