Clinical Program Manager

Responsibilities

• Manage and lead a Clinical Research team to share the corporate vision, deliver franchise, functional and team objectives and support the team in their personal development.
• Ensure appropriate training and onboarding for the Clinical Research group at large and manage distribution of workload to ensure project success.
• Mentor the team to develop specific short and long-term objectives and lead problem solving and resolution efforts in management of risks and issues.
• Coordinate and oversee monitoring strategies (e.g., centralized, on-site or risk-based monitoring) to ensure protocol compliance, data quality, and subject safety.
• Develop and review centralized operational and monitoring tools and metrics (e.g., enrollment, data quality, deviations, monitoring findings) and escalate risks or issues as appropriate.
• Partner with internal teams and external vendors/CROs to ensure efficient trial execution, adherence to SOPs, and continuous process improvement.
• Support inspection readiness through maintenance of compliant documentation, oversight of monitoring deliverables, and participation in audit responses as needed.
• Analyze data from experiments, clinical trials and publications and support the creation of appropriate device claims and regulatory required clinical documentation (e.g. clinical evaluation reports, clinical study reports, usability engineering files).
• Develop evidence strategy and clinical study designs in conjunction with cross-functional stakeholders.
• Manage and facilitate Investigator Initiated Research (IIR) program.
• Design and manage real world evidence studies (e.g., health outcomes research and registries).
• Provide support for technical documentation (e.g., PMS, PMCF, CER, CEP) as needed and support design verification and validation studies.
• Represent Clinical on new product development teams (or assign a Clinical Affairs team member), contributing to product design reviews, risk management, and clinical strategy planning.
• Lead development and execution of clinical scientific communications plans aligned with evidence strategy, including abstracts, posters, manuscripts, and clinical content for internal and external use.
• Oversee preparation, review, and approval of scientific materials to ensure accuracy, consistency, and alignment with regulatory, legal, and compliance requirements.

Qualifications

• Bachelor's degree in Basic or Life Sciences, Engineering, Health Sciences, Medicine, Nursing or related medical discipline with 8 years relevant experience in Clinical Research.
• Minimum of 1+ years prior management experience or demonstrated ability to lead and align teams to achieve project milestones.
• Experience supporting clinical trials in all phases (start-up, conduct, and closeout) including activities such as protocols, informed consent, case report forms, site management (initiation & training), monitoring, and device accountability, etc.
• Experience working in field of medical devices and thorough knowledge of ICH/GCP Guidelines, ISO 14155, and FDA regulations and EU MDR, including a basic understanding of regulatory requirements in other countries.
• Experience contributing to cross-functional new product development teams throughout the development lifecycle.
• Demonstrated clinical research leadership in evidence generation strategies.
• Strong project planning and management, critical thinking, decision making, and problem solving.
• Experience with statistical methods, interpretation and data collection techniques preferred.
• Ability and willingness for occasional travel.