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Parexel Madrid, Community of Madrid, Spain Clinical Trial Manager - Spain - FSP at Parexel Overview We are recruiting a Clinical Trial Manager based in Spain. Home‑based role dedicated to a single sponsor. You will manage individual clinical trials and programs as part of the Clinical Trial Working Group. Expect exciting career challenges with a healthy work‑life balance. Tasks on the role Manage external vendors and contract research organizations Prepare study documents (Monitoring Manual, Study Operations Manual, Source Data Verification Plan, Laboratory Manual) Coordinate design of study materials (CRFs, patient diaries, study participation cards, source documents) Assist with protocol development and study report completion Manage monitoring activities (may include routine on‑site monitoring) at study sites to assure adherence to GCPs, SOPs, and protocols Provide guidance, direction, and management to CRAs Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; 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/ICH guidelines Ensure the trial master file is current and maintained Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials Requirements (Knowledge and Experience) Strong experience in clinical trial documentation and processes (protocols, CRFs, monitoring plans) Strong experience in clinical trials management Strong experience in data management and query resolution in clinical trials Overall knowledge of site management and monitoring procedures Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines) 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 Education Degree in the life sciences field preferred Contact For more details contact Seniority level Mid‑Senior level Employment type Full‑time Job function Health Care Provider, Science, and Research Industries Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care #J-18808-Ljbffr
