Associate Medical Director- Oncology ,Sponsor-Dedicated(m/w/x)

Requirements

• Medical degree from accredited, internationally recognized medical school
• Minimum 5-7 years' experience in clinical medicine
• Robust, current knowledge of scientific, clinical, regulatory, commercial, competitive landscape
• Knowledge of federal, local regulations, guidelines for clinical research

Tasks

• Serve as a core member of trial teams.
• Manage medical content in Clinical Trial Protocols.
• Collaborate with project, safety, writing, and trial teams.
• Provide medical input for CTP updates.
• Define medically critical data, processes, and risks.
• Contribute to the Integrated Quality and Risk Management Plan.
• Participate in risk discussions during trial conduct.
• Co-author the Clinical Quality Monitoring Plan.
• Align CQMP with IQRMP risks and mitigations.
• Provide medical input on important protocol deviations.
• Review and support decisions on iPDs.
• Address and communicate clinical quality issues.
• Contribute to preparing core trial documents and milestones.
• Design eCRFs and translate medical questions.
• Develop Information for CRF Completion (ICC).
• Develop Data Review Plans.
• Specify lab parameters.
• Contribute to Data Transfer Agreements and alerts.
• Manage medical content for patient information.
• Manage medical content for informed consent.
• Manage medical content for trial monitoring manuals.
• Manage medical content for communication and training plans.
• Manage medical content for statistical analysis plans.
• Contribute to patient narrative preparation.
• Plan and review medical sections of Clinical Trial Reports.

Work Experience

Education

Languages