Clinical Affairs Manager
The Clinical Affairs Manager is responsible for devising and executing clinical trial strategies for cardiovascular therapeutic products. The Manager will define the clinical requirements for a wide range of medical device projects and drive the clinical development and validation strategies, and he/she will collaborate with the Regulatory Affairs team, as well as other teams to successfully support multiple PMA and 510(k) submissions in the United States and CE marking under the MDD and MDR in the EU. These trials are complex, consisting of several sub-studies and multiple clinical sites. The position provides senior clinical leadership internationally and across functions, reports to the Head of Quality and Regulatory, located in Vancouver, BC, Canada. The position may be located in Canada or the United States.
- Represent Clinical Affairs in the strategic planning of medical device projects, and collaborate with the Regulatory Affairs, Research, and Business Development teams to develop the medical strategies for new products and define their potential medical value.
- Establish general clinical affairs policies and procedures in accordance with applicable regulatory requirements, GCP, international standards and industry practice, as well as monitor proposed regulations and guidance documents related to clinical trials and personal data privacy to ensure that all clinical activities, policies, and procedures remain compliant with these requirements.
- In close collaboration with key opinion leaders and internal Subject Matter Experts, drive the design of clinical studies and ensure their adequacy to successfully support premarket regulatory submissions and post-market surveillance of the company’s product in the US, Canada, and Europe.
- Ensure, either by direct execution or by providing oversight, the timely completion and compliance of clinical trial activities, including:
- Design, implementation, and validation as required of electronic CRFs, clinical database and data transmission, and management infrastructure
- Budgeting and negotiation of contracts with investigational sites, investigators, and their clinical research staff
- Recruitment and initiation of investigational centres
- Collaboration with Clinical Training Coordinator to plan, deliver, and document training to investigators, study nurses, and research assistants
- Authoring and maintenance of required study documentation (trial master file, site study binders, study protocol, CRFs, informed consent forms, etc.)
- Coordination of monitoring, auditing, and GCP compliance of investigational sites
- Adverse event triaging and collaboration with the Regulatory Affairs team for the timely submission of mandatory and periodic safety reports to regulatory bodies, IRBs, and ECs
- Coordination with external monitors and CROs as required
- Site closure
- Study report authoring and approval
- Provide support to the Regulatory Affairs team for the timely completion of regulatory submissions.
- Build, develop, and provide leadership to the Clinical Affairs team of the organization.
- Serve as the scientific and clinical liaison between internal teams and external groups such as key opinion leaders, professional, and public health organizations, advisory boards, regulatory authorities, and CROs.
Education and Experience
- M.Sc. or Ph.D. preferably in biomedical engineering or biotechnology
- 10+ years of experience in medical device clinical trial research and regulatory submissions for clinical studies (IDE, IRB, Health Canada ITA, European CA and EC) ranging from early feasibility to pivotal and post-market stages
- 5+ years of management experience, with proven track record of delivering projects on time and promoting high performance behaviors within a team
- Prior experience working with cross-functional project teams, IRBs, and business partners
- Experience in interfacing with key opinion leaders including physicians, specialty clinical, and research teams
- Thorough, working knowledge of clinical trial design and biostatistics, with a clear understanding of the intersection between study design, statistical design, regulatory strategy, and intended use.
- Understanding of regulations and guidelines governing medical devices, with a broad knowledge of requirements and best practices in Clinical Affairs, Regulatory Affairs, and Product Development.
- Ability to provide medical expertise and leadership to the Clinical, Regulatory Affairs, Quality Assurance, Research, Engineering, and Business Development teams.
- Proven ability to multitask, collaborate in cross-functional teams, work independently, and manage multiple time-sensitive high priority projects.
- Excellent communication skills and working knowledge of English grammar, punctuation, and overall writing skills, with the ability to write clinical trial reports and documentation independently.
- Critical-thinker with excellent negotiation skills and the ability to address complex situations independently.
- Ability to develop or revise clinical trial procedures and processes, and working knowledge of clinical trial auditing.
- Willingness to travel up to 40%.
Preferred Knowledge/Skills, Education, and Experience
Professional designations are not required, but training and certificates in clinical research, quality, or regulatory affairs are a plus (e.g., ACRP, SOCRA, GCP, RAC, etc.).
How to Apply
To apply for this position, please send a résumé and cover letter to firstname.lastname@example.org. Please use “127 Clinical Affairs Manager” as the subject line of your email.