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Clinical Team Lead
Functie omschrijving
You will:
- Manages the clinical activities in the assigned countries in accordance with previously defined performance indicators in terms of both quality and quantity and implements actions as necessary;
- Monitors the clinical activities in accordance with protocol, SOPs, applicable laws and ICH-GCP guidelines;
- Ensures that information is conveyed effectively between the sponsor, Project Manager and the CRA team;
- Ensures adherence of the CRA team to study timelines;
- Reviews monitoring visit reports;
- Performs accompanied site visits;
- Contributes to the development of study-specific documentation;
- Trains CRAs with regard to protocol, Case Report Form (CRF) and study-specific procedures;
- Participates in, and jointly organises meetings for investigators and CRAs;
- Ensures the correct query process is followed in collaboration with Data Management;
- Ensures the correct reporting and follow-up of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions;
- Supports the CRA team during inspections by healthcare authorities or audits;
- Ensures the reliable documentation and archiving of study documents, both at the study site and ‘in-house’.
Functie eisen
- Higher level of education preferably in a (bio)medical field;
- A minimum of 3 years’ experience as CRA in the pharmaceutical and/or CRO industry;
- Work experience as a Clinical Team Lead or a simular position is an advantage;
- Experience with therapeutic area Infectious Diseases, ENT and/ or Pulmonary is a pre;
- Up-to-date knowledge of legislation and regulations and ICH/GCP guidelines;
- Experience with multi-centre, international studies;
Bedrijfsprofiel
An open culture in an innovative and dynamic environment with inspiring colleagues and good working conditions.An environment where you have room to be creative, take initiative and have direct influence on the way you work. Good opportunities for (personal) growth and further development.
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