ABIOMED is a leading provider of circulatory support medical devices that offer a continuum of care to acute heart failure (heart attack) patients.  This is a unique opportunity to join a reputable, well-capitalized, growing company that has the exciting feel of a "start-up company" as we bring new technologies to the Cath Lab and the Cardiac Surgery suite.  ABIOMED is the developer of the world’s only fully implantable FDA-approved artificial heart, and the world’s smallest catheter-based Ventricular Assist Device.

ABIOMED is seeking an experienced Clinical Research Safety Manager to be responsible for monitoring clinical trial execution with respect to patient safety

Responsibilities Include:

• Processing, evaluating and quality checking (QC) Serious Adverse Events and Post Marketing Adverse Events within agreed timeframes and to a high standard of accuracy while ensuring compliance with business rules, standard operating procedures and global regulatory requirements.

• Representing the Clinical Affairs team on cross-functional teams that deal with safety matters and special projects related to our investigational and marketed devices.

• Evaluating and quality checking Serious Adverse Events and Post Marketing Adverse Events to ensure accurate and consistent data entry and processing from source documents while emphasizing timeliness and quality.

• Reviewing and incorporating medical knowledge for logic checks (CRF interpretation, report review); reviews and interprets lab test results for clinical significance.

• Ensuring accurate and consistent coding of medical history, and adverse event terms.  Reviewing data coding including adverse events, medical histories, physical examinations, and medication coding as required. Generate patient narratives and first medical reviews.

• Ensuring that each case receives appropriate medical review and that all reports which require expediting to FDA are processed swiftly and appropriately within required timelines.

• Identifying follow-up data required and ensuring that appropriate measures are taken to obtain follow-up data while working with in-house CRAs, Project Managers, Clinical Research Operations Director and other ABIOMED partners (e.g., Clinical Research Organizations, Central and CoreLabs and outsourced Monitors). 

• Providing internal and external (in-services in clinic and partners) staff education concerning ABIOMED research protocols and safety directives.

Required Skills:

• BS in life science required.
• Must have 3+ years of experience in clinical research and/or safety.
• Work experience in the medical, science or as an RN is a plus, cardiovascular background preferred.
• Experience with prior clinical trials for cardiovascular medical devices is preferred
• Must be familiar with laws, regulations, standards and guidance governing the conduct of clinical studies
• Must be familiar with medical terminology
• Computer skills in: PowerPoint, Word and Excel (MS Office)
• The ability to organize and prioritize work to meet deadlines is essential
• Occasional travel required.

Located in Danvers, MA, conveniently located off of Route 128, and with operations in Europe, we are looking for motivated leaders who share our mission of Recovering Hearts and Saving Lives ^TM while leading the industry in technology and innovation.  ABIOMED is the place to prove your ability to deliver results and join a world class team!

Click the following link to apply online:

https://www.hirebridge.com/v3/application/applink.aspx?cid=5524&jid=86040

**ABIOMED is an Equal Employment Opportunity/Affirmative Action Employer: M/F/D/V