Study Start-up LEAD
Warszawa
NR REF.: 1020006

For our client, an international well-known CRO, we are currently seeking Study Start-up Leaders/ Polandwith an international experience in coordination of Study start- up activities.


The successful candidate will be responsible for the coordination and lead of the Study Start Up teams for multi-country studies, driving the teams' efficiency and adherence to study procedures and timelines, establishing regulatory requirements and site contracts to ensure a smooth start-up process, liaising and coordinating with Project Managers to facilitate consistent communication for start up.

Responsibilities will also include the following: Provide regional planning, risk and status, Oversee regulatory and ethics committee submissions, ensuring submissions timelines are met and any questions are followed up promptly, Oversee site contracting, establishing contract templates for the study, along with fallback language and the negotiation process, Ensure regulatory documents are collected in a timely manner, facilitating the release of investigation product to the sites as soon as recruitment is permitted

Applications are invited from candidates with the following background/experience:

Preferably with a degree in Life Sciences, you will have previous submissions/dossier experience within clinical studies for either a CRO or Pharmaceutical company on international level !!