Clinical Project Manager

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 looking for a Clinical Project Manager to plan, design and implement high quality clinical studies to ensure safety and effectiveness of ABIOMED’s products. They will also provide clinical training for proper device implantation and operation for investigators, cath lab and operating room staff and coronary unit staff.

 

This is an in-house, strategic role that requires advanced skills in clinical trial management in the business settings. The role requires excellent leadership and organizational skills. As a leader, you will be responsible for the planning, implementation and execution of large global studies. The current role requires you to:

 

· Run the standard clinical trial operations, assess risks and opportunities during the execution of the trials and propose solutions to the executive team.

· Develop and maintain clinical trial project timeline, manage study budgets, and prepare routine operations reports to management and top executives.

· Oversee progress made by contracting CRO on weekly a basis.

· Be the study champion.  Represent ABIOMED and act as the prime contact on behalf on the company with the CRO, different vendors and all clinical sites and partners.

· In partnership with other key ABIOMED members, launch strategic initiatives with KOL and other investigators to drive patient/site enrollment and maintain high momentum for the trial.

· Identify trial challenges early in the process, propose potential solutions and lead the team for resolution.

· Prepare and participate in presentation of protocols and other study conduct requirements at study webinars and investigator meetings.

· Ensure the trial is compliant with respect to all regulatory and business expectations.

· Mentor and train Jr. Clinical Research Staff

Job Qualifications:

· Bachelor's-level degree in science/health related field, RN/MD preferred (will consider less with proven solid track record).

· Professional, self starter, very enthusiastic, catalyst and committed to make the difference

· 7+ years of successful clinical trial management experience required; Cath lab related products is a plus.

· Must be familiar with the laws, regulations, standards and guidance governing the conduct of clinical studies.

· Ability to manage and provide tactical and leadership guidance to clinical team.

 

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/application/appchoice.asp?jid=69620

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