Description 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 Vice President of Regulatory, Quality and Clinical Affairs 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: 10-20% 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. #J-18808-Ljbffr Kerecis
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