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Sr. Clinical Research Manager

The Sr. Clinical Research Manager will be representing VOC in product development as well as optimization of clinical performance of existing and new products. The Sr. Clinical Research Manager will also support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements. Monitors adherence to protocols and directs studies through to completion. Manages clinical and regulatory files and may maintain clinical inventory of consumables intended for distribution to investigational sites. May interact with investigational sites, clinical consultants, Contract Research Organizations and other vendors. Selects, develops and evaluates personnel to ensure the efficient operation of the function. Critical indicators of Sr. Clinical Research Manager success:   1.      Focus on clinical research and support new as well as ongoing clinical research and clinical trials 2.      Coordination of all post launch clinical research 3.      Understand trade definition and robust stream of data vs. market 4.      Ability to work cross functionally with medical, legal, and regulatory functions 5.      Ability to generate clinical data that supports product commercialization 6.      Ability to manage global KOL's  The primary responsibilities of Sr. Clinical Research Manager: -       Oversee the design, planning, initiation, monitoring, and close-out of post-market medical device clinical research studies. -       Manage study submission and maintenance with respect to required Institutional Review Board, Independent Ethics Committee, or other local regulatory body oversight. -       Ensure strict study compliance with 21CFR, ICH GCP, or other applicable regulations. -       Ensures proper reporting of study related adverse events, adverse -       Create and control accuracy of post-study analysis for scientific conference abstracts and presentations. -       Ability to contribute to generation of peer-reviewed scientific journal publications. -       Participate as needed in regulatory audits. -       Ability to establish and maintain strong working relationships with clinical investigators, site staff, and industry KOL. -       Oversees management of Clinical Research Associate staff. -       Ability to interact with cross-functional departments: clinical, marketing, sales, regulatory, research The Sr. Clinical Research Manager will have one direct report and will work cross-functionally with R&D, Operations, Quality, Regulatory and Marketing. The Sr. Clinical Research Manager will receive a competitive compensation package inclusive of an annual base salary and an annual short-term incentive performance bonus.  Mandatory Minimum of bachelor's Degree in clinical research, engineering, health sciences, related scientific field Mandatory Medical, Clinical, Engineering discipline preferred  Mandatory Knowledge of FDA, GCP and other regulatory requirements required Mandatory 5+ years experience in clinical research, medical devices strongly preferred Mandatory 2+ years experience in clinical research management Mandatory Medical Device OR Diagnostics experience Excellent written and verbal communication skills required Working knowledge of statistical analysis Ability to interact with senior management and manage without direct authority Process driven, passion to details and ability to drive complex program through timetable and overcome obstacles. Leads with personal power to influence others and to gain trust and respect from staff at all levels of the organization. Develops effective relationships with key stakeholders, project team members and support staff. Negotiates across the organization's various functional areas while fostering teamwork, respect, and a healthy rapport with all co-workers. Excellent interpersonal, organizational as well as verbal and written communication skills Proficiency with Microsoft Windows Office tools and Microsoft Project Strong technical and analytical ability Traveling up to 30% of the time                  
Salary Range: $161K - $184K
Minimum Qualification
5 - 7 years

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