15 days ago
The Clinical Scientist will help carry the clinical research experiment through its entire life cycle, and report to the Director of Clinical Development.
- Design clinical study with Clinical Development team.
- Comply with regulatory standards to write and coordinate clinical study documents.
- Collaborate with Medical lead and Clinical Operations lead to troubleshoot and present clinical trial results internally.
- Collaborate with biometrics and Pharmacovogilance Leads to reveiw and interpret data. Contribute to database lock, statistical analysis plan, preparation of Clinical Study Reports, and Investigator’s Brochure.
- PharmD with 3-5+ years or MS with 5-10+ years of clinical research experience.
- Strong knowledge of drug development experience in all phases of clinical trial planning, start-up, conduct, reporting, and publishing required.
- Experience interacting with development operations, medical monitors, and clinical investigators.
- Strong understanding of ICH, GCP, and regulatory requirements.
- Ability to work proactively and independently, with high sense of urgency and ability to manage multiple tasks.