Description:
The successful candidate will be responsible for the coordination and lead of the country 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 Manager to facilitate consistent communication for start up. The SSU Team Lead should be the team motivator for the Study Start Up team.
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.
• Minimum of 5 Years of experience in a clinical trial lead environment, preferably with Study Start Up Lead experience
For a full Job Spec and further information please call Linda at +353 1 2784671 or email your CV in the strictest confidence to
ldunne@thornshaw.com .
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