Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission ofRecovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
Patients First | Innovation | Winning Culture | Heart Recovery
The Sr. Clinical Training Coordinator supports the Associate Director, Clinical Operations and Sr. Training & Education Specialist(s) in planning and coordinating all aspects of internal and external training activities within clinical trial operations.
Primary Duties and Responsibilities:
- Assist Associate Director, Clinical Operations with mapping out a comprehensive training program for new hires including the preparation of electronic and paper based on-boarding materials.
- Assist with assessing training needs for new and existing employees as well as external vendors (i.e., core labs, CRO/ARO etc.) and identifying training activities/systems to address competency gaps, as identified.
- Set up, update, and maintain internal/external training systems.
- Responsible for creating and updating training SOPs, work instructions and other training processes as necessary.
- Responsible for reviewing/assessing study specific training plans to ensure accuracy and consistency across studies.
- Ensure documentation including protocol, device and all systems trainings are QC'd and filed in a timely manner.
- Liaise with internal subject matter experts regarding instructional design and assist with the development of training aids.
- Assist with the design and application of assessment tools to measure training effectiveness.
- Track and report on training outcomes to clinical management.
- Evaluate and make recommendations regarding training material and methodology.
- Manage and coordinate logistics for internal training activities including venues and equipment, as necessary.
- Manage GCP Training process for Internal team members.
- Review and maintain Clinical Training Plans in collaboration with Sr. Clinical Program Manager.
- Manage external vendor training requirements and ensure proper documentation is in place.
- BS degree with 3 years relevant clinical research experience, Sponsor or Clinical Research Organization.
- Familiarity of clinical trial operations, ICH, GCP Guidelines and other applicable Regulatory requirements.
- Good working experience in a team environment across multi-functional areas.
- Highly organized, self-motivated, detail-oriented, proactive, and accurate.
- Ability to work with urgency and thrive in a high-energy, fast-paced environment.
- Demonstrate excellent communication, verbal and written, and interpersonal skills.
- Demonstrate advanced proficiency in MS Office Suite: Word, PowerPoint, Excel, Project and Published
- Experience coordinating Clinical Training Programs and working with Clinical Training Systems strongly preferred.
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.