Study Start-Up Specialist
San Mateo Metro Area, CA
- Responsible for all study start-up related activities for assigned studies in collaboration with other clinical research stakeholders.
- Prepare country level Informed Consent Form (ICF) and obtain ethics committees and local regulatory authorities approval. Prepare ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country.
- Maintain and analyze study start-up metrics on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.
- Liaise and collaborate with relevant authorities to further enhance clinical trial process, government policies, laws, via innovative approaches
- Responsible for study budget and contracts negotiation in collaboration with Contracts Manager/Associate, as required and ensure compliance with Fair Market Value (FMV) in the country.
- Bachelor's degree preferably in a life science related field with 3-5 years of clinical operations experience with a biopharmaceutical company
- Demonstrated knowledge and understanding of clinical trials and experience in managing projects.
- Demonstrated knowledge and understanding of ICH-GCP.