Manager of Clinical Operations

Job Description SUMMARY OF DUTIES Responsible for development, implementation, conduct, and management of operations for multiple clinical studies, across various therapeutic areas for medical devices. ESSENTIAL FUNCTIONS PERFORMED Leads, directs, and mentors the clinical operations team responsible for management and execution of all clinical trials Responsible for assisting in generation of supporting study documents such as CRFs, Informed Consents and Investigator Brochures, as well as SAE and death reports, IDE annual updates to the FDA, and progress summaries for safety reporting Create investigational plans, and infrastructure for conducting studies Ensure accomplishment of key clinical milestones, including study enrollment Assists in identifying, qualifying, and initiating clinical sites Ensures quality of data collection, including conducting quality assurance of data monitoring and data management Participates in the budget preparation for clinical studies and monitors performance of the budget Participates in SOP development Oversees project management performance, including timely execution of site clinical trial agreements and IRB approvals Assists in hiring departmental personnel Trains new clinical trial assistants and project managers and assists in training of clinical trial monitors Manage contract employees such as part-time monitors and vendors for clinical trial services Collaborates with senior management and performs other related duties and tasks, as required    SUMMARY OF MINIMUM QUALIFICATIONS Education and/or experience equivalent to a bachelor's degree in a biological science and five years of clinical trial or related operational in medical device, pharmaceutical drug development, biotech or CRO industries Proven track record of ever-increasing responsibilities in a clinical development organization Proven skills in leadership, management and communication Self-motivated, self-directing, strong attention to detail and excellent time management skills Excellent writing and oral presentation skills Strong analytical skills Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs Up to 20% domestic and foreign travel required Excellent knowledge of ICH/GCP including relevant Guidance documents from (FDA, ICH, and EMEA etc.) Strong leadership skills, ability to lead, mentor, coach and manage teams Ability to effectively collaborate across all relevant functions involved in clinical trials Project Management Excellent time management skills, ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful manner PREFERRED QUALIFICATIONS Experience with global clinical trial authorization, Competent Authority, Ministry of Health and Ethics Committee Approvals (Canada, France, Greece, Germany, Austria, Italy, and Egypt.) Experience with Bioresearch Monitoring (BIMO) Inspections at Site and Sponsor level IDE, PMA, 510(K), De Novo 510(k) Submission Experience Experience in the medical device industry   Merit Medical Systems, Inc., an Equal Opportunity Employer M/F/D/V, is a dynamic, progressive and innovative company with a strong global presence. Our culture is highly energetic, family friendly, values its employees, and promotes them as standard business practice. 730-16708
Salary Range: NA
Minimum Qualification
5 - 7 years

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