Manager Clinical Affairs- Lowell, MA

SUMMARY:
To manage clinical trials as assigned for Clinical and Regulatory Departments.

ESSENTIAL FUNCTIONS:

The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.

§ Initiate and manage investigation sites.
§ Implement and monitor clinical studies for compliance with protocol, FDA regulations and GCP guidelines.
§ Verify that source documentation supports clinical study data.
§ Coordinate monitoring duties with field personnel.
§ May supervise clinical staff personnel as necessary.
§ Participate in investigator recruitment and selection.
§ Conduct investigator / site training for purposes of collecting study data and study requirements.
§ Maintain frequent communication with sites and implement appropriate problem solving techniques, when indicated.
§ Manage disbursements for clinical studies.
§ Assist with data management, compilation, and interpretation of data.
§ Participate and lead multidisciplinary project teams (including consultants) to coordinate all aspects of project management.
§ Communicate effectively with other department members and site personnel.
§ Proactively identify study issues and intervene quickly and appropriately.
§ Willingness to travel.

NON-ESSENTIAL FUNCTIONS:

In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.

QUALIFICATIONS:

§ BA / BS in health science field from a four-year college or university; or four years related experience and / or training; or equivalent combination of education and experience.
§ Four to five years of clinical trial experience with one to two years in the area of cardiovascular devices is required.
§ Ability to establish and manage multi-site clinical studies.
§ Knowledge of FDA procedures / processes and hospital research protocol (academic and community)
§ Previous management of personnel and clinical understanding of surgery.
§ Operating room experience in the field of nursing, or as a physician’s assistant and other operating room experience highly desired.
§ Strong project management skills, attention to details, strong organizational skills and highly motivated.
§ Working knowledge of regulatory requirements and experience with PMA submissions in the device industry highly desirable.
§ Ability to travel for site support
§ Ability to balance the various political and personality issues associated with working with multiple physicians.
§ Computer literacy required, knowledgeable of MS Word and Windows.