The Manager of Clinical Affairs is responsible for the design and successful execution of clinical trials that demonstrate medical product safety and efficiency while ensuring that trials are conducted in full compliance with all applicable regulatory requirements.
Working in close collaboration with the regulatory affairs department, and reporting directly to the VP technology, the Manager of Clinical Affairs takes the leadership role for execution, analysis and interpretation of clinical results for the preparation of regulatory submissions and publications.
SUMMARY:
- Strategic translation of business objectives into clinical requirements for clinical trials, investigator-sponsored studies, publications, and meeting regulatory requirements for clinical evaluations and post-market surveillance.
- Overall responsibility for design of clinical trials including protocol development, clinical trial discussions with regulatory authorities, and development of timeline and budget.
- Manage the process of screening, qualifying, and selecting, and contracting with investigators, sites and vendors required for conduct of clinical trial.
- Obtain necessary clinical trial approvals from IRBs and regulatory bodies such as the FDA, Health Canada, and Competent Authorities.
- Ensure studies are on track for site initiation, patient recruitment and enrollment, and take corrective actions where necessary to address issues.
- Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.
- Maintain surveillance of published literature and clinical results or Opsens and competitive products across all pertinent indications for strategic purposes and use in regulatory submissions.
- Develop, maintain and expand collaborations with outside clinical investigators, researchers and thought leaders to facilitate the optimum performance of clinical development programs.
- Ensure adherence to protocols and compliance with regulatory guidelines as well as SOP procedures.
- Identify clinical training needs and develop training materials for in-house and clinical site use.
- Provide oversight of investigator-sponsored studies.
- Develops budgets for all clinical projects and adheres to company financial goals.
REQUIREMENTS
- BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines.
- Minimum 5 years in clinical management position in the medical device industry or academic/hospital clinical research environment.
- Additional 5+ years direct experience in clinical trial management.
- Solid track record in successfully executing Phase I – III clinical trials.
- Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines & FDA and applicable international regulations.
- Excellent interpersonal, written / verbal communication & organizational skills.
- Collaborative team player.
- High level computer skills required (e.g. MS Word, Excel, PowerPoint).
- Willing & able to travel domestically and internationally, as required (up to 40%).
