Sr. Clinical Research Associate

Overall Responsibilities:

Provides leadership and direction to Clinical Affairs group. Directs the preparation of varoius clinical protocols, investigational plans, etc. Develops general and specific clinical studies clinical strategies for the sucess of new products. Responsible for developing and administering the Clinical Affairs budget.

Position Duties & Responsibilities:

Direct the clinical research efforts required to support regulatory approval of new and modified products
Develop, prepare and administer the Clinical Affairs budget
Develop clinical Strategies for new products
Develop and administer clinical education programs
Provide clinical consultation to senior management regarding clinical issues related to new products
Provide support and assistance, as required, to the Vice President, Regulatory & Clinical Affairs
Responsible for mentoring and developing the professional skills of Clinical Affairs employees
Assess resource needs and allocate departmental resources to assure accomplishment of corporate goals for new product approvals
Foster credibility of the Clinical Affairs groups with stakeholders such as FDA, Product Development, Manufacturing, etc.
Other duties as assigned
REQUIREMENTS


Professional Experience Requirements:

10+ years of prior experience in clinical trials
5+ years of management experience in medical device clinical affairs
5+ years of experience in the Medical Device Industry
Specific experience with Class III medical devices
Expert understanding of medical device regulations
Knowledge of statistical concepts as they apply to clinical trials
Management experience with CRO's
Expert understanding of clinical trial methodology, including GCP's