The Clinical Study Manager is responsible for:
Ensure study set up and conduct in accordance with Good Clinical Practice.
Arrange for regulatory and ethics, submissions and approvals.
Develop study protocols, develop study documents, including CRF’s.
Provide input into the protocol development process and study analyses phases.
Select investigators and take part in the selection process of third parties, such as CRO’s and central labs
Monitor clinical studies and/or coordinate (co-)monitoring activities, if CRO’s are involved.
Arrange site contracts and manage budget and timelines
Coordinate the process of data management and statistical analyses.
| De eisen
|
Master’s or PhD degree, preferably in a life science or related scientific discipline.
At least 3 years of experience as CRA in (international) clinical research in the (bio-) pharmaceutical industry.
Experience in monitoring of clinical studies according to ICH-GCP guidelines.
Excellent communication skills and responsiveness to interact with a multidisciplinary project team and with all other parties involved, such as investigators and CRO's
Able to train site staff and coach others in conduct of clinical trials.
Familiar with medical terminology, and some knowledge of statistics will be useful.
Fluency in English.
Independent, teamplayer, communicative, analytical and output focused.
| De arbeidsvoorwaarden
|
Good salary, 5% gratification, 30 holidays, non-contributory pension, parttime work possible.
| | Contactinformatie
|
Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Drs. Femke Buurma
Consultant Medical
Biltstraat 443
3572 AW Utrecht
tel 030 231 7350
|
 |
| | |
