Manager, Clinical Operations (USA) - (Job Number: 0714642)

Manager, Clinical Operations (USA) - (Job Number: 0714642) DescriptionEthicon Inc. a member of Johnson and Johnson's Family of Companies, is recruiting for a Manager, Clinical Operations located in Somerville, NJ. Ethicon, Inc. develops and markets products for surgery, wound management and advanced wound care treatment . Products are marketed through four divisions: Ethicon Products for precise wound closure and tissue repair; Cardiovations for minimally invasive cardiac procedures; Ethicon Women's Health & Urology for minimally invasive women's health procedures; and Johnson & Johnson Wound Management for hemostasis and advanced wound care.The Manager, Clinical Operations ensures efficient and high quality generation of clinical data in support of the global Ethicon Franchise and JNJ Umbrella businesses; develop strategic and tactical approaches for utilization of global resources for planning and conduct of regional and local studies. Collaborates with Director Clinical Development, Biostatistics, Data Management, Clinical Managers, Project & Data Managers, Regulatory Affairs, Finance, Quality Assurance, Information Management and Compliance. The Manager, Clinical Operations is responsible for designing, developing and maintaining global clinical operations architecture and infrastructure. Oversight of Clinical Administration Project Managers, Coordinators and other assigned personnel. Resourcing 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. Mentoring and career development activities of direct reports. Bachelor's degree in Biological Science or related discipline required, advanced degree preferred. Minimum 4 years related scientific/technical experience required. Minimum 2 years experience at the Senior Project Manager level required. Experience with clinical regulated and /or non-regulated studies required. 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 required. Experience in project management responsibilities for clinical studies in tissue engineering required. Medical Device / ISO experience preferred. Experience managing a CRO network re: all phases of clinical study implementation and reporting required. Excellent interpersonal, communication and presentation skills required. Computer skills including Microsoft Word, Excel, Power Point, Access required. Up to 25% domestic / international travel required. If you want to explore the many small-company environments behind the big-company impact of the Johnson and Johnson Family of Companies, bid on this position today! Apply Now