Clinical Team Lead

1. Together with the project manager, is responsible for planning, organizing and executing international clinical trials from initial set up to study closure;
2. Leads, guides and oversees the CRA teams in the assigned countries in accordance with previously defined performance indicators in terms of both quality and quantity and implements actions as necessary;
3. Ensures the clinical trial is monitored in accordance with protocol, SOPs, applicable laws and ICH-GCP guidelines;
4. Ensures that information is conveyed effectively between the sponsor, Project Manager and the CRA team;
5. Reviews monitoring visit reports;
6. (Contributes to the) development of study-specific documentation;
7. Trains CRAs with regard to protocol, Case Report Form (CRF) and study-specific procedures;
8. Jointly organises meetings for investigators and CRAs;
9. Ensures the correct query process is followed in collaboration with Data Management;
10. Ensures the correct reporting and follow-up of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions;
11. Supports the CRA team during inspections by healthcare authorities or audits;
12. Ensures the reliable documentation and archiving of study documents, both at the study site and ‘in-house’.

1. Higher level of education preferably in a (bio)medical field;
2. A minimum of 3 years’ experience as CRA in the pharmaceutical and/or CRO industry;
3. Experience in other clinical trial operational management roles;
4. Experience in coaching and training of CRAs is a pre;
5. Experience with therapeutic area cardiovascular and/or CNS is a pre;
6. Up-to-date knowledge of legislation and regulations and ICH/GCP guidelines;
7. Experience with multi-centre, international studies;
8. Experience with regulatory / EC submissions/ start-up phase of clinical studies;
9. Adequate command of written and spoken Dutch and English.

Our company culture can best be described as dynamic, open, co-operative, motivational, collegial, and inspirational. We set clear goals, work hard to attain them, and celebrate our successes.

Additional information

This position/ vacancy is for at least 32 hours.