Director of Clinical Research
2 weeks ago
Description
Summary
The Director of Clinical Affairs is responsible for all clinical aspects of medical device development projects at all stages of the product life cycle, for clinical affairs activities, and for special projects. This full-time role reports to the Senior Vice President of Regulatory Affairs and Quality Assurance and is located in the Minneapolis, Minnesota, office.
Essential Functions
Select Clinical consultants and Clinical Research Organizations (CROs) and manage their contracts
Recruit, hire, train, manage and facilitate the career development of Clinical staff
Prepare and track the company’s Clinical trials budget on an annual basis
Allocate resources and budgets to various department projects and oversee their progress
Participate in preparation of Clinical operating plans and objectives in alignment with company and department strategies
Supervise the implementation of clinical programs and track their progress
Oversee the planning of new clinical programs and the development of clinical protocols
Review and approve submissions of protocols and reports to the relevant regulatory authorities and Institutional Review Boards (IRBs) or Ethics Committees (ECs)
Interact with Investigators and IRBs on financial and compliance issues
Oversee the proper collection, analysis and presentation of clinical data
Review and approve final Case Report Forms, Edit Checks and Clinical Study Databases
Oversee development and maintenance of department standard operating procedures (SOPs)
Assure compliance of department activities to the relevant regulations, department SOPs and corporate requirements
Develop and manage the process for clinical regulatory document preparation and submissions for clinical studies (IDE submissions, IRB/EC submissions, etc.)
Other tasks and responsibilities as assigned
Anticipated travel: 35%
Requirements
Competencies
Strong knowledge of FDA regulations and International Conference Harmonization (ICH) and Good Clinical Practices (GCPs) guidelines
Demonstrated experience with European clinical study requirements and CE marking, EUMDD / MDR, MEDDEV 2.7.1 Revision 4, ISO 14155 and other relevant regulation
Regulatory/Clinical document writing
Ability to independently lead clinical research
High interpersonal skills
Fluency in English
Excellent teamwork skills
Strategic thinking
Presentation skills
Leadership skills
Education & Experience
Master’s degree in science or health-related field
8+ years of experience in the medical device required, with a portion of that being in a Medical/Clinical Affairs role
6+ years of experience in laboratory, preclinical and Clinical Research roles required
Leadership or people management experience is an asset
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time. Kerecis is an equal opportunity employer.
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