Patients First | Innovation | Winning Culture | Heart Recovery
The Sr. Clinical Project Manager reports to the Associate Director, Clinical Programs and is responsible for managing the operational activities of a portfolio of early feasibility studies. Plan, develop and follow systems and procedures to ensure optimum compliance in accordance with GCP/ICH guidelines and FDA regulations. Ensure operating quality and efficiency. The Sr. Clinical Project Manager works closely with the Clinical Research Associates, Medical Affairs and Regulatory Departments to execute the trial She/he will need to engage and work closely with CROs and Vendors that execute the study operations, Core Labs and DSMBs/CECs.
Primary Duties and Responsibilities:
- Responsible for comprehensive study management for clinical study, for example protocol and database development, site management and monitoring, project planning,
- Chair team meetings for assigned studies ensuring goals and deliverables are clearly defined, and issues, decisions, risks and actions are appropriately tracked
- Responsible for project development & performance tracking and risk management
- Oversee and contribute to development of key study documents including, but not limited to study protocols, protocol amendments, study plans and procedure manuals, project tools, informed consent forms and clinical study reports,
- Accountable to conduct clinical research programs in accordance within approved project plan, compliance to company standard operating procedures and applicable regulations.
- Analyze and develop action plans for investigational sites, vendor and administrative issues
- Plan, prepare and present at Investigator and Research Coordinator Meetings
- Provide Quality Assurance support and management level representation during audits and inspections.
- Direct experience successfully conducting Pre-Market Clinical strategies (early feasibility studies preferred) to align with business objectives; experience in Class III cardiovascular devices
- BS degree in Science, Engineering, or related medical/scientific field; MS or graduate degree preferred
- Minimum of five years’ experience in clinical research with at least two years in the medical device industry in a leadership role
- Expertise with GCP and regulatory compliance guidelines for clinical trials required
- Experience with site and sponsor level FDA BIMO investigation(s) preferred
- Polished communication and presentation style
- High attention to details and accuracy; Excellent prioritization, organizational skills and advanced, metric-driven project management skills
- Certified Clinical Research Professional (CCRP) and/or Project Management Professional (PMP) preferred
- Positive, self-starter, willing to work in an extremely fast-paced environment looking for growth and making a difference in patient lives
- Excellent interpersonal communication skills; Works effectively on cross-functional teams
- ~35% travel to Sites, Vendors and Conferences