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 development and management of clinical studies.

· Assist in the development and management of clinical studies, program budgets, contracts and resources. Monitor clinical studies for compliance with protocols, regulations and guidelines.

· Design clinical protocols and case report forms as well as initiate and monitor clinical studies.

· Lead and/or participate in the preparation and presentation of clinical study results.

· Plan and coordinate resources and timelines.

· Perform analysis of clinical data trends.

·Prepare clinical reports for regulatory submissions as well as schedule, write and/or review submissions.

· Participate in and lead multi-disciplinary project teams (including consultants) to coordinate all aspects of project management.

· May supervise personnel as necessary.

Candidate Requirements:

· We seek a professional with 5-7 years of experience and/or training in clinical affairs or equivalent combination of education and experience.

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

· 1-2 years experience in cardiovascular devices is desired.

·Ability to establish and manage multi-site clinical studies.

· Knowledge of medical device directives, regulations for clinical trials and hospital research protocols (academic and community).

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

· Travel of 20% - 30% is required.

· 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.