This position, located at Bard Electrophysiology Division in Lowell, MA, and reports to the Vice President of Regulatory and Clinical Affairs. You will be responsible for the design and execution of clinical studies in the development and approval of medical devices for human use. You will work with both internal and external personnel such as engineers, market and/or product managements, statisticians, clinical research associates, physicians, programmers and others involved with the planning and implementation of clinical trials. This position has the responsibility to ensure, either through their own direct efforts or through others, (i) there is adequate project planning, (ii) there are adequate resources available (time, funding and personnel), (iii) each project is successfully initiated, conducted and terminated.

You will be expected to:

· Develop project plans.

· Initiate protocol development and case report forms in accordance with US and international regulations, corporate and divisional procedures and policies.

· Negotiate and coordinate agreements and contracts; e.g. investigator agreements, CRO contracts, core lab contracts, etc.

· Initiate clinical studies including investigational review board or ethics committee approval, training of site personnel and CRAs.

· Monitor clinical sites.

· Complete, coordinate and/or oversee task completion; including device accountability, payment management and working with CROs, data management centers, core labs, clinical events committees, project teams.

· Assure compliance with SOPs, the protocol and US and international regulations (including scheduling of audits).

· Develop, maintain and track budgets, generate reports.

·Develop and maintain written internal procedures for the clinical operation.

·May be responsible for supervising employees or individuals outside of the company who are involved with clinical trails and data management.

Candidate Requirements:

· We seek a professional with 4-5 years of clinical research experience plus two or more years of broad Senior CRA experience preferably in medical devices.

· We seek a professional with a health science degree. (BA/BS, MA/MS preferred).

·Strong project management skills, attention to details, strong organizational skills and highly motivated.

· Computer literacy required - MS Word and Windows.

·For the best fit, you should be a hands-on, results-oriented professional who is a strong team player with excellent written and oral communications, and capable of working independently.

Compensation:

A compensation package will be designed to attract outstanding talent and will include a base salary, performance bonus, a long-term incentive plan and an attractive benefits package.