Job Properties
  • Job Type
    Full-time Position
  • Category
    Research & Science
  • Languages
  • Experience Required
  • Degree Required
    • Province
    • Date Posted
      January 15,2022
    • Entrusting Package
    • JSS
    • VISA
    • IMG_6430
    • Career Consultation

    Clinical Trial Manager EU

    De organisatie

    In this position as Clinical Trial Manager, 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 Manager? Please apply via the button. If you have any questions please reach out the recruiter mentioned below.

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