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Job #03474

About our client Our client is a young pharmaceutical and medical device company that is focused on the development and commercialization of innovative therapies for a variety of indications including traumatic brain injury and advanced wound care. The company has an experienced management team, strong financing and a technology portfolio that is regarded as one of the most progressive in the Life Sciences industry. This is a unique opportunity for someone that wants to put their drive and to work for an entrepreneurial organization with a bright future. Position Location Clinical Trial Manager Raleigh, NC Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage clinical studies in accordance with the company SOPs, GCP, FDA and ICH regulations. 2) Assist in management of various clinical study contractors including selected CRO staff and contract CRA’s (domestic and international). 3) Oversee the collection and validation of all study and site specific regulatory documentation necessary for initial drug shipment and filing to the IND and NDA. 4) Conduct reviews and source verification of clinical issues. 5) Oversee site selection including completion qualifications visits and site initiation. 6) Manage all site related start-up activities (Investigator recruitment and selection, collection of regulatory documents, IRB/EC Submissions). 7) Manage investigative site activities by overseeing contracted activities, pre- study site evaluations. 8) Handle study monitoring including on-site visits to ensure protocol adherence. 9) Meet clinical operational timelines (study start-up to completion of clinical study report). 10) Write and coordinate investigator brochures. 11) Organize and conduct group investigators meetings. 12) Develop clinical monitoring plans and provide management with study updates. 13) Participate in protocol development and CRF design. 14) Oversee technical writing (protocols, Reports of Prior Investigation, clinical section of IDE and PMA). 15) Resolve site problems and ensure timely resolution on site issues and /or data query issues. 16) Oversee study termination (resolving data query forms, reviewing record retention, securing investigator report to the Ethics committee or IRB as required). Requirements 1) Bachelor’s degree in Biological Science or health related field. 2) Minimum 1year experience as a Clinical Trials Manager (managing CRA). 3) Minimum 2 years experience as a CRA. 4) Minimum 1 year field –monitoring experience. 5) Minimum 3 years overall clinical trial experience in the pharmaceutical/ biotech industry. 6) Experience in overseeing staff at offshore locations. 7) In-depth knowledge and understanding of ICH and FDA regulations; GCPs as well as US IND and NDA regulations. 8) Expertise in all aspects of clinical operations, monitoring and overseeing contract resources. 9) Medical device experience. 10) Strong interpersonal and organizational skills. 11) Expertise in writing key clinical documents. 12) Valid U.S. passport. 13) Ability to travel into Israel.