In search of a physician career change opportunity or a new non-clinical career? An executive search firm is currently looking to fill the following position: Manager, Clinical Operations, in New York. Join this company that develops and markets products for surgery, wound management and advanced wound care treatment.
The Manager, Clinical Operations ensures efficient and high quality generation of clinical data, develop strategic and tactical approaches for utilization of global resources for the planning and conduct of regional and local studies, and collaborates with Director Clinical Development, Biostatistics, Data Management, Clinical Managers, Project & Data Managers, Regulatory Affairs, Finance, Quality Assurance, Information Management and Compliance. Responsibilities include: designing, developing and maintaining global clinical operations architecture and infrastructure; oversight of Clinical Administration Project Managers, Coordinators and other assigned personnel; resource allocation for regional / local clinical study plans including budgets, personnel and vendors; allocating resources to projects based on business priority, clinical plan and geographic spread of clinical sites; implementing infrastructure to ensure high standards of research conduct and compliance requirements; overseeing and coordinating study supply requirements and reconciliation according to CFR/GCP/ICH requirements, including study article procurement and tracking through study implementation, monitoring and closure; ensuring development & maintenance of all critical inter-company, intra-company and external interfaces and processes in clinical research; overseeing Vital Documents retention and records management processes; clinical study financial management: budget creation and maintenance, accruals, reporting; developing and Maintaining Standard Operating Procedures and clinical processes; coordinating clinical personnel training & development; clinical Information Management Systems and Technology; managing external vendors liaison with QA audit function; and mentoring and career development activities of direct reports.
Qualifications include: a Bachelor’s degree in Biological Science or related discipline, advanced degree preferred; a minimum 4 years related scientific/technical experience; a minimum 2 years experience at the Senior Project Manager level; experience with clinical regulated and /or non-regulated studies; knowledge of medical, scientific principles and terminology in general, cardiac, gynecologic and wound management surgery/medicine preferred; experience with FDA study requirements, CFR, GCPs/ICH Guidelines; experience in project management responsibilities for clinical studies in tissue engineering; medical Device / ISO experience preferred; experience managing a CRO network including all phases of clinical study implementation and reporting; excellent interpersonal, communication and presentation skills; computer skills including Microsoft Word, Excel, Power Point, Access; and the ability to travel up to 25% domestic / international travel required.
If you are interested in this position, please email a cover letter and your CV to info@prnresource.com, and we will provide them to the search firm looking to fill this position.
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