Senior Clinical Research Physician
Há 4 dias
We are seeking a Senior Clinical Research Physician to provide critical medical input to global clinical studies. As a key member of our team, you will advise on patient safety and well-being, collaborating with cross-functional teams to ensure successful study outcomes.
Responsibilities:- Advise clients, project teams, sites, regulatory agencies, and vendors on medical matters.
- Collaborate in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and scientific presentations.
- Review and analyze clinical data to ensure patient safety in clinical studies.
- Evaluate reported data for accuracy, completeness, and verifiability.
- Address safety issues across the study from sites and the study team.
- Verify Medical Dictionary for Regulatory Activities listings.
- Participate in bid defense meetings.
- Support Pharmacovigilance activities.
- Identify program risks and create mitigation strategies with Clinical Operations.
- Lead clinical development advisory boards and safety monitoring boards.
- Maintain study team compliance with FDA, EMEA, ICH, and GCP guidelines.
- Medical Doctor degree.
- Oncology Fellowship certification.
- Minimum 5 years of experience as a practicing Oncologist.
- Fluent working proficiency in English.
- Excellent communication, presentation, and analytical skills.
- Strong problem-solving, team, and detail-oriented abilities.
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