A company is looking for a Study Start-Up Manager.
Key Responsibilities
Accountable for study planning, SSU activities, and activation deliverables in compliance with regulations
Collaborates with local IRBs / IECs and Health Authorities to ensure timely study start-up activities
Oversees local SSU team activities to achieve start-up timelines and quality execution
Required Qualifications
Minimum 5 years' experience in clinical operations with project management oversight
Understanding of clinical drug development, particularly trial set-up and execution
Strong project management capabilities and ability to mediate complex issues
Thorough knowledge of international drug development standards (GCP / ICH) and health authority regulations
Bilingual in French and English (spoken and written)
Study Manager • Alexandria, Virginia, United States