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Accentuate Staffing is working with a top International mid-sized CRO to find a Director, Medical Monitoring. This is a great opportunity to work in a collaborative environment and have input into the company’s clinical strategy. This position works remotely.
- Work cross-functionally to define, plan and provide Medical Monitoring to clinical development studies
- Extensive interaction with academic thought leaders to optimize clinical trial strategies and clinically manage the conduct of the clinical trials
- Collaborate with Project Management, Clinical Operations and all departments in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports, clinical study reports, manuscripts and different scientific presentations
- Identify Program risks, and create and implement mitigation strategies with Clinical Operations
- Responsible for review and analysis of clinical data including safety monitoring
- Ability to organize and lead clinical development advisory boards and safety monitoring boards
- Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
- Review and sign off clinical documents with respect to medical relevance
- M.D. degree; oncology or hematologist-oncologist
- Board certified Oncologist with an active US medical license
- Minimum 10 years total clinical research experience
- Knowledge of key opinion leaders in the areas of oncology/hematology highly desirable
- Familiar and comfortable with clinical concepts, practices and FDA regulations regarding clinical research trials experience with FDA interactions leading to drug approval strongly preferred
- Familiar with data processing methods plus general knowledge of clinical medicine, oncology and medical terminology
- Ability to interact with and train clinical monitors and physician investigators, and build constructive, trusting and respectful relationships with colleagues at all levels within and outside the organization
- Must possess excellent leadership, communication, and organizational skills and be able to exercise sound critical thinking and problem-solving skills and execute position responsibilities with minimal guidance