VacatureNIEUW: Clinical Team Lead [exclusief]
Korte omschrijvingVoor één van onze klanten ben ik op zoek naar een Clinical Team Lead. De Clinical Team Lead is verantwoordelijk voor het management en aansturen van CRAs op (inter)nationale klinische studies.
BedrijfsprofielA growing company with a large diversity in local and international trials.
Functie omschrijvingTasks and Responsibilities
Monitors the progress of the clinical activities in the assigned countries in accordance with protocol, SOPs, applicable laws and ICH/GCP guidelines and implements actions as necessary;
Reviews monitoring visit reports relating to the clinical trial;
Performs accompanied site visits;
Ensures adherence of the local team to study timelines;
Contributes to the development of study-specific documentation;
Trains CRAs and other local staff 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 study 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’;
Ensures that information is conveyed effectively between the sponsor, Project Manager and the study team.
Functie eisenDesired Skills & Expertise
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;
Experience in coaching and training of CRAs is a pre;
Up-to-date knowledge of legislation and regulations and ICH/GCP guidelines;
Experience with multi-centre, international trials;
Adequate command of written and spoken Dutch and English.

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