Clinical Study Start Up Manager
Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.
We are seeking an experienced Clinical Study Start-Up Manager to join our growing Clinical Operations team. You will play a foundational role in the execution of all start-up activities for assigned clinical trials, working hands-on to ensure that clinical sites are selected, qualified, and activated efficiently. Your primary goal will be to accelerate study timelines by managing the collection of essential documents, preparing regulatory and ethics submissions, and facilitating the execution of site contracts, all while ensuring strict adherence to GCP and regulatory standards.
How you might spend your days
- Overseeing the collection, rigorous review, and tracking of all essential site documents required for study activation, including Investigator CVs, medical licenses, financial disclosures, and FDA1572/QIU Forms
- Ensuring all start-up documentation is high-quality, filed correctly, and maintained in an inspection-ready state within the Trial Master File (TMF)
- Collaborating with the Regulatory team in preparing and reviewing comprehensive
