Job Description
Responsibilities
- Develop, review, and collaborate on scientific content for clinical documents including protocols, informed consent forms, final study reports, and regulatory submissions.
- Oversee patient safety by reviewing risk profiles, monitoring adverse events, and ensuring compliance with safety policies and procedures.
- Contribute to investigator selection, lead study start-up training, and provide protocol-specific guidance to investigators and site staff.
- Serve as a medical and protocol subject matter expert for clinical operations, monitors, investigators, and ethics committees.
- Support data analysis, publication development, and planning/attendance at scientific meetings (e.g., symposia, advisory boards, congresses).
- Establish and maintain strategic relationships with external experts and thought leaders.
- Monitor competitors, track therapeutic advancements, and stay in...