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Job #03562

About our client Our client is a rapidly growing CRO based in Canada that focuses on conducting research and providing services for bioequivalence and early-stage studies in the life science industry. The company has an experienced management team, a strong pipeline of clients, and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Director of Clinical Operations Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Supervise the Clinical Department 2) Promote and maintain company's mission and objectives within the Clinical Department 3) Ensure implementation and application of clinical SOPs and GCPs regarding ethics, safety and health for clinical staff and volunteers 4) Plan, implement and maintain processes and departmental structures ensuring rapid study turnaround and fluidity of internal, inter-departmental and external communication 5) Ensure efficient clinical staff hiring, equipment purchases and site organization in order to fulfill project schedules 6) Report any issues regarding limitations to operational capacity (e.g., recruiting, clinical space, staff availability) promptly to the General Manager and Project Management 7) Participate in monitoring visits with sponsors and internal or external auditors 8) Ensure that accurate and fair documentation will accompany recommendations to upper management regarding salary modifications, new responsibilities or corrective/punitive measures for clinical staff members 9) Meet the clinical managers and all clinical staff regularly to reinforce departmental and company objectives 10) Oversee subject compensation issues and manage complaints from study subjects or volunteers 11) Perform yearly evaluations of staff (direct reports) 12) Represent the company at pharmaceutical conferences, etc. Requirements 1) B. Sc. or a higher-level degree in Medical, Pharmacy, Nursing or equivalent field 2) 5+ years of experience in a clinical research organization and/or pertinent field preferred 3) Minimum 3 years of management experience in leading clinical operations in a CRO/Pharma environment 4) In-depth knowledge of GCPs and applicable regulations pertaining to ethics and clinical assessments performed on human volunteers 5) In-depth knowledge of federal and provincial regulations pertaining to medical and/or nursing care preferred 6) Exceptional organizational, leadership, communication and problem-solving skills 7) Innovative, creative, detail-oriented, people-oriented individual 8) Proficiency in Outlook, MS-Office, Acrobat Reader, Word Perfect