Staffing services voor de Life Sciences industrie

Clinical Trial Lead

Clinical Operations Utrecht 38 uur W&S #1264

De organisatie

In this position as Clinical Trial Lead, with a focus on a rare disease, you will manage all current and new clinical trials for the company as primary point of contact for the CRO’s (CRO oversight, initiation, coordination). A very interesting environment with flexibility, broad responsibilities, an international focus and everything just a little different than the usual positions within pharma! You will be reporting to the Medical Affairs Manager.

De functie

The purpose of the role (full job description is available):

Management of Clinical Trials:

  • Coordination of current clinical trials;
  • Initiation and protocol development of new clinical trials;
  • Primary point of contact for Investigator Initiated Trials and CRO’s;
  • Coordination of clinical regulatory procedures;
  • Management of study budget
  • Provision of internal and external medical training
  • Support of the development of the clinical publication strategy
  • Support of the development of clinical publications such as, but not limited to; abstracts and manuscripts
  • Development of scientific documents such as, but not limited to; quarterly scientific paper overview

Your main responsibilities:

  • Management of all types of clinical trials; from begin to end – including corresponding regulatory procedures (if required);
  • Preparation & review of clinical study documents such as, but not limited to; the study protocol, interim reporting and the clinical study report;
  • Selection of and liaising with Clinical Research Organisations for the performance of new/ongoing/previous clinical studies;
  • Liaising with the Pharmacovigilance Department for the reconciliation of study-related adverse events and the annual submission of the DSUR.

Het profiel

  • Degree in related discipline and/or proven experience in Pharmaceutical sector within clinical trial management;
  • It is essential that you are social, pro-active, self-motivated, eager to learn, focused, flexible and possess excellent organisational skills;
  • Fluent in written and spoken English; with strong communication skills.

Het aanbod

  • 38 hours work week, 33 holidays, Mobile phone and laptop, Pension scheme, Sport allowance, Collective health insurance and other benefits.

Inlichtingen bij

Interested in this role as a Clinical Trial Lead? Please apply via the button. If you have any questions please reach out the recruiter mentioned below.

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Meer informatie over deze vacature

Albert Hollemans

Associate Director Business Development