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 Clinical Trial Liaisonreportsdirectly to the Director of Clinical Research and Medical Affairsand is responsible for planning, implementing and executing job duties asassigned for clinical studies.
Principal Duties And Responsibilities
- Work closely with theMedical Directors and Associate Medical Directors on specific clinical trialsbased in Danvers, MA, to develop site enrollment strategies and case support for experimental studies, first-in man investigations and larger multicenter clinical trials to optimize strategic goals
- Responsible for Clinical Enrollment Site strategies in Clinical trials for Impella Platform in US
- Attend unit implants in the labs and operation rooms of Clinical Trial sites and ensure protocol compliance by site staff
- Team up withClinical Operations team members to meetwith Clinical Trial Sites (e.g., physicians, physician office groups at hospitals) to identify their clinical needs, goals, and constraints related to patient care and to discuss and demonstrate how company products can help them to achieve their goals
- Educate Investigators and site staff on clinical trials and their protocols
- Train Investigators and site staff on administration of the investigational product
- Accelerate enrollment of patients through referrals and awareness initiatives
- Attend Investigator meetings to provide education and/or training
- Identify new sites for consideration
- Providing initial and continuous training, education and support for clinical center personnel on clinical trial protocol, clinical process, products and features under investigation, and procedures involving those products and features.
- Operational leadership: Interfaces with project management, functional team members, site coordinators and investigators to ensure a timely and precise subject enrollment for assigned clinical protocols.
- Manage, train and advise Clinical Sites on all aspects of Clinical Protocol and ensure strict adherence to all inclusion and exclusion criteria
- Develop site training programs and mentor team members to optimize application of knowledge and performance
- Collaborate with cross-functional teams in Clinical operations like Project Management and Site Managers to provide clinical knowledge and medical guidance as needed
- Provide 24/7 enrollment support along with fellow CTLs, MSL, and medical officers
- Advanced degree with strong cardiovascular knowledge required. NP, PA, RN, PharmD, MD, DO
- 3+ years Clinical Field support for Clinical Trials background in clinical research is preferred
- Strong clinical knowledge of etiology/pathology of cardiovascular diseases and patient management issues especially coronary artery disease, revascularization procedures, and cardiogenic shock
- Proven prior experience in scientific data interpretation, presentation and publication is required
- Strong knowledge of compliance and regulations such as Health Insurance Portability and Accountability Act (HIPAA), Food and Drug Administration (FDA), International Conference on Harmonization (ICH) and Good Clinical Practice (GCP)
- Excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike
- Self-motivated leader able to manage and motivate site research teams, establishing goals; monitoring results to achieve tactical goals
- Proficient with Microsoft Outlook, Word, and Excel; and understanding of database programs is extremely helpful.
- Proven ability to work in a multicultural, global environment
Role will require travelin US (about 70%).
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.