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Job: Director, Clinical Affairs, Contego Medical, Raleigh, NC

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General Information


Job title: Director, Clinical Affairs
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Job location: Raleigh, NC  27607 United States
Requisition code:
Date posted: 03/08/2018
Job category:Clinical Research
Research and Development
Employment type:Full time
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Job Description

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Contego Medical is currently recruiting for a Quality Systems Administrator to join an international medical device company in the Raleigh area. The Director, Clinical Affairs will report to the Vice President, Quality and Clinical Affairs. This position will have a leadership role in executing the company's clinical strategy including study design, protocol development, project management and clinical trial execution in order to evaluate the safety and effectiveness of new and existing products.

Key Responsibilities
The Director, Clinical Affairs will have responsibilities including, but not limited to:
- Support development of clinical strategies
- Design and execute global studies for regulatory submissions, reimbursement and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management activities.
- Ongoing project management for preapproval and post market clinical trials
- Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers.
- Oversee clinical data analysis and review.
- Other tasks as required or assigned.
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Job Requirements

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Required experience:
- 10+ years medical device clinical trial management experience, cardiovascular / vascular device preferred.
- B.S. degree (minimum) in scientific field.
- Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
- Strong knowledge of FDA and international regulations and guidelines pertaining to clinical studies.
- Good prioritization and organizational skills.
- Effective written, verbal and presentation skills.
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