Clinical Trial Manager
Purpose of the role:
The Clinical Trial Manager (CTM) is responsible for the start-up and conduct of one or more trials through all phases of Clinical Trial Management (Plan/Prepare, Initiate, Conduct, Close out), in accordance with the appropriate quality standards including ICH/GCP and other applicable regulations and guidelines. (S)he sets direction and supervises all country and site related trial activities - usually performed by Vendors - through evidence-based pro-active management and oversight.
- Provide operational input in trial related documents and processes, such as task lists, outsourcing specifications, APO, Protocol, ICF, CRF, CTMS and IXRS development and set up;
- Primary point of contact/counterpart for respective function(s) at Vendor(s), e.g. Lead CRA, Project Manager, Subject Recruitment Agency (if applicable) and for Trial Management Team members;
- Ensure oversight on Vendor(s) performance to deliver trial data in time, budget and quality (according to the contractual agreement) by;
- Set up and regularly analyze the ‘operational’ key risk indicators and other identified occurrences not only, but also through Central Data Review output;
- Review Trial Status Reports and Site Visit Reports provided by Vendor(s);
- Review and approve Key Documents/Functional Plan(s) provided by Vendor(s) (e.g. Monitor Guide, Monitoring Plan);
- Perform Site Visits (planned visits for CRA/CRO surveillance and triggered visits e.g. for site relationship management, issue resolution or to learn from high performing sites);
- Identify, monitor and assess potential risks connected to monitoring/country and site management prior to trial start and throughout the trial, define mitigations and contingencies and convey lessons learned/improvement needs from trial to CTM department level.
- Medical or Life science degree or equivalent qualification;
- Several years of experience as CRA and at least some years of international trial management experience;
- Thorough knowledge of ICH GCP, regulations and general processes of data handling;
- Good verbal & written communication in English;
- Very good communication skills;
- Good analytical and problem solving skills;
- Proven experience to work in multidisciplinary teams;
- Ability to operate proactively and independently by using various systems and databases (CTMS, eCRF, CDR tool, etc.);
- Demonstrated solid relationship building skills combined with demonstrated good negotiation skills.