Adecco Technical is currently seeking a senior clinical trial manager for a large biotech company in the RTP, NC area. Only local candidates are being considered at this time due to the immediate timeline/need of this individual. In this role you are expected to manage clinical trial operations (large and/or complex multicenter studies). Manage/direct the project teams throughout the conduct of assigned clinical trials under the guidance of Operations Director, as well as oversight accountability for CRAs.
Previous management experience and IVD clinical studies experience is required for consideration. Please review our requirements below - as well as instructions on how to apply.
Education and Experience Required:
<!--[if !supportLists]-->· <!--[endif]-->Bachelor's degree in Medical Technology, biochemistry, or related life science field.
<!--[if !supportLists]-->· <!--[endif]-->Three years previous experience managing prospective clinical in vitro diagnostic (IVD) trials required.
<!--[if !supportLists]-->· <!--[endif]-->Experience managing project team personnel required.
<!--[if !supportLists]-->· <!--[endif]-->Three year minimum requirement managing people.
<!--[if !supportLists]-->· <!--[endif]-->Experience leading project teams through the start-up, trial conduct, data management, and report writing of FDA regulated prospective IVD clinical trials required.
<!--[if !supportLists]-->· <!--[endif]-->Knowledge of ICH guidelines, FDA regulations, and guidelines for clinical diagnostic trials required.
<!--[if !supportLists]-->· <!--[endif]-->Ability to work on problems of diverse scope where minimal direction is given for situational analysis. Ability to exercise judgment within broadly defined practices and policies to determine appropriate action. Normally determines methods and procedures on new assignments and provides guidance to lower level personnel.
<!--[if !supportLists]-->· <!--[endif]-->Ability to manage stringent deadlines required. Proven ability to provide solutions to a variety of technical problems of moderate scope and difficult complexity required.
Education and Experience Preferred:
<!--[if !supportLists]-->· <!--[endif]-->Higher education strongly preferred.
<!--[if !supportLists]-->· <!--[endif]-->Previous experience managing and designing PMA IVD clinical trials strongly preferred.
<!--[if !supportLists]-->· <!--[endif]-->Experience with site selection and managing international diagnostic clinical trials desired.
<!--[if !supportLists]-->· <!--[endif]-->Knowledge of international trial (evaluations) preferred. PMA trial experience strongly preferred.
Supervisory Responsibility:
<!--[if !supportLists]-->· <!--[endif]-->Matrix management of 4-40 multidisciplinary project team members, depending upon project assignment and number of contracted monitors.
<!--[if !supportLists]-->· <!--[endif]-->Clinical Research Associates will report directly to this position.
If you meet the requirements and are interested in pursuing this position - please e-mail a copy of your resume/cover letter to: wesley.knapp@adeccona.com for immediate consideration.