Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: “Patients First.” With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 2,000 employees form one of the fastest growing medical technology companies in the world. Abiomed attracts and retains exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
Job Description:
The Sr. Clinical Project Manager reports to the Manager, Clinical Programs EMEA and is responsible for managing the operational activities of a portfolio of assigned Abiomed clinical studies. This includes the planning, development and follow-up of systems and procedures to ensure optimum compliance in accordance with GCP/ICH guidelines, FDA and EU regulations including GDPR to ensure operating quality and efficiency. The Sr. Clinical Project Manager works closely with the Senior Clinical Program Manager, Clinical Research Associates, Medical Affairs and Regulatory Departments to execute the trial. This role will engage and work closely with CROs and Vendors that execute the study operations, the 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 with 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
Job Qualifications:
- Direct experience successfully conducting Pre/Post-Market Clinical strategies 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
- Solid EU regulatory knowledge including experience with Ethics Committee and Competent Authority submissions in Germany, Switzerland, UK, Netherlands, Italy and France
- Experience with site and sponsor level Regulatory Authority 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
- 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 Conference and Abiomed Aachen office
We offer:
Pleasant, open corporate culture with a strong mission: "Recovering Hearts, Saving Lives"- Comprehensive induction program with structured onboarding plan throughout the orientation phase
- Company pension allowance of up to 1,500 euros per year and capital-forming benefits
- Benefit packages for occupational disability insurance and company group accident insurance
- Full cost coverage for a job ticket in the Aachen or Berlin area
- Various health programs and a leasing option for a job bike
ABIOMED is an equal opportunity employer. We support equal opportunities for our employees regardless of ethnic origin, skin color, religion, gender, sexual orientation, gender identity, disability or nationality.