|Vacature||Clinical Research Manager|
|Korte omschrijving||Voor een klein, innovatief biotechnologisch bedrijf in (medische) voeding ben ik op zoek naar een Clinical Research Manager die ervaring of affiniteit heeft met voeding.|
|Bedrijfsprofiel||Mijn klant is een startend biotech bedrijf dat voedingsmiddelen ontwikkelt met een klinisch bewezen gezondheidsvoordeel voor specifieke patienten- en consumentengroepen.|
|Functie omschrijving||Responsibilities and tasks (working closely with the other team members):|
You initiate, monitor and coordinate (multi-center) clinical trials with (medical) food products in patients and healthy volunteers.
You act as the lead function between the company, as sponsor, and the CROs, the sites and other related parties making sure we leverage all capabilities and build/maintain the momentum to execute the clinical program within time and budget according to the appropriate quality standards.
You coordinate protocol and CRF writing.
You coordinate CRO and site selection
You coordinate contract management with CROs and other vendors.
You set up and maintain the internal documentation.
You work and interact across functions within the NutriLeads team core team and with its consultants.
|Functie eisen||Skills and capabilities:|
You are action oriented, have a can-do mentality and can work effectively in a small cross-functional team and with many external collaborators.
You have a scientific background (MSc / PhD) in the life sciences and at least 5-year (preferrably 10 years) experience in clinical trial management.
You have broad experience in clinical trial management and are able to maintain the overview, proactively identify and mange risks, switching easily from strategic decisions and and overall supervision to action-oriented troubleshooting.
You have a track record and strong capabilities to build and manage effective collaborations and vendor relations.
You have experience with all phases of a clinical trial including initial design, CRO and site selection, protocol and CSR writing, monitoring and final reporting.
You have been involved in the production of food or food additives/ingredients.
You have experience in developing and implementing GCP documentation systems and are up to date on the pertinent regulatory requirements.
You are experienced in project management and proficient in English.
The currently ongoing trials are run in Amsterdam, France, Ireland and Scotland, which will require travelling.
Affinity with the science underpinning the preventative health impact of nutrition and experience with working within a pharmaceutical/ Nutritional company is a pre.
Starting date no later than September 1st, 2018 is a pre.