Clinical Trial Manager

​The Clinical Trials Manager (CTM) will be a member of the client's Development Operations team. The Clinical Trials Manager will manage individual clinical trials and/or programs as part of the Clinical Trial Working Group. •Essential Functions•+ ​Manage external vendors and contract research organizations + Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual + Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents + Assist with protocol development and study report completion + Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols + Provide guidance, direction, and management to CRAs + Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities + Coordinate study supplies + Negotiate contracts with vendors of clinical trial services + Review Informed Consent Forms, CRFs, and study related materials + Plan and participate in investigator meetings + Assist and support data query process + Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals' SOPs and FDA and ICH guidelines + Ensures trial master file is current and maintained \#LI-LG4 \#LI-REMOTEEEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.