Job Summary
Our client is seeking a Clinical and Medical Affairs Manager to join their team. The incumbent supports clinical research programs and medical affairs activities across North America. This role involves developing and overseeing clinical trials, ensuring compliance with regulations, maintaining clinical documentation, and contributing to business development. Reporting to the Chief Regulatory, Clinical, and Medical Affairs Officer, this position requires effective collaboration with cross-functional teams and external stakeholders.
Key Responsibilities
- Write, review, and refine clinical trial protocols for accuracy and compliance.
- Collaborate with teams to develop study designs and objectives.
- Oversee protocol alignment with study goals, ethics, and feasibility.
- Incorporate stakeholder feedback into protocol drafts.
- Coordinate with vendors for medical monitoring, data management, and statistics.
- Manage clinical trial planning, execution, and adherence to timelines, budgets, and quality standards.
- Address trial challenges to maintain study integrity and compliance.
- Assist in planning and tracking study budgets to ensure cost efficiency.
- Evaluate and recommend investigational sites across North America.
- Support medical affairs activities, including training sessions, advisory boards, and presentations.
- Build and maintain relationships with clinicians, investigators, and industry professionals to support collaborations.
- Ensure compliance with SOPs, GCPs, and applicable regulatory requirements.
Qualifications
Bachelor’s degree with 5+ years or Master’s degree with 3+ years of clinical and medical affairs management experience in pharmaceuticals or medical devices.Strong project management skills, with the ability to prioritize and meet deadlines.Excellent written and verbal communication skills.Bilingual in English and French is an asset.Proven ability to work effectively in a team environment.Experience in clinical trials from conception to publication.Familiarity with medical affairs activities, including advisory boards, IITs, and educational program development.Thank you in advance for your interest, only individuals deemed to have the skill set and experience to fit the role will be contacted.
Lock Search Group is a National Executive Recruitment firm with 11 offices in Canada and one in the United States, a staff of more than 30 Consultants and Associates, and expertise in 11 major disciplines. Our mission is to provide exceptional Recruitment and Consulting Services to clients and candidates. We apply our experience and expertise to deliver solutions with a personalized approach that focuses on client needs and candidate goals.
Follow us on LinkedIn!