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