Global Clinical Trial Manager - FSP

Job Summary 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 the Pharmaceuticals’ SOPs and FDA and ICH guidelines • Ensures trial master file is current and maintained Collaborative Relationships • Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials. Skills • Oversee all aspects of clinical trials from initiation to closeout, ensuring timely completion within budget through effective project management. • Identify and resolve issues that arise in a timely manner during trial execution to minimize delays and maintain study integrity, employing strong problem-solving abilities. • Effectively manage multiple tasks, deadlines, and priorities in a complex clinical trial environment • Clearly convey information and expectations to cross-functional teams, investigators, and stakeholders Knowledge and Experience • 5+ years of direct experience managing global clinical trials end to end in a CRO or pharmaceutical organization • Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines) • Experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans) • Experience of data management and query resolution in clinical trials • Overall knowledge of site management and monitoring procedures Education • Bachelor's Degree in the life sciences field required #LI-CF1 #LI-REMOTE