Position Summary:

The Sr. Clinical Program Manager will develop, plan, and execute product-specific clinical research strategy for BMT; develop and author clinical evaluation plans (CEPs) and Clinical Evaluation Reports (CERs) for BMT medical devices, while ensuring consistency with regulations, quality standards, commitments and goals; provide analytical, scientific and strategic support to product roadmaps for BMT’s existing and future medical devices; support regulatory and product development initiatives with current, in-depth knowledge of cardiovascular science; professionally and credibly represent BMT when presenting to numerous audiences: physicians, clinical staff, clinical and advisory boards and internal teams; and contribute significantly to sales and marketing materials intended to educate and inform customers.

Primary Duties & Responsibilities:

Medical Writing Activities

• Write Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMCF Plans/Reports, and other related documentation in a clear, concise manner.
• Maintain thorough knowledge of BMT products, as well as competitive products for a thorough understanding of the State of the Art.
• Ensure compliance by following internal SOPs and external standards (MEDDEV 2.7/1, 2017 MDR, etc) and guidances (FDA, MDCGs etc).
• Audit support relevant to CER and PMCF materials, including responses to queries from Notified Bodies.

Clinical Research Activities

• Contribute to the development, planning, execution and interpretation of PMCF research projects consistent with all applicable regulations, guidelines, and policies.
• Develop and lead collaborations with external researchers, CROs, and physicians, for both ACIST-sponsored clinical studies, and physician-initiated studies.
• Receive and solicit proposals for investigator-initiated research and presentations which align to the clinical research strategy set in collaboration with Marketing.
• Facilitate review and selection of proposals with internal board.
• Participate in annual budget planning.
• Manage clinical relationships and engage leaders in advisory boards, expert panels and other forums.
• Works closely with biostatisticians on statistical analysis plans and clinical data analysis.

Scientific Evidence Activities

• Clinical lead for maintaining the clinical claims matrix, working in conjunction with marketing product managers.
• Maintain comprehensive literature database to provide in-depth knowledge and understanding of current clinical practices and research relevant to ACIST products.
• Identify clinical evidence gaps to build into ACIST’s clinical research strategy.
• Maintain and disseminate clinical summary information.
• Contribute to materials on relevant clinical studies.
• Collaborate cross-functionally the development and dissemination of new evidence.
• Support the development of medical device labeling including promotional material based on results of clinical research, including providing appropriate reference and support based on valid scientific evidence.

Product Development Activities

• Contribute to the development of new technologies and products by identifying unmet clinical needs.
• Participate in product roadmaps activities for ACIST’s medical devices.
• Provide competitive clinical analysis.
• Support development of communications/labeling materials.
• Serve as an internal expert on current clinical topics.