Clinical Trial Manager
hace 2 semanas
Parexel Madrid, Community of Madrid, SpainClinical Trial Manager - Spain - FSP at ParexelOverviewWe 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 roleManage external vendors and contract research organizationsPrepare 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 completionManage monitoring activities (may include routine on‑site monitoring) at study sites to assure adherence to GCPs, SOPs, and protocolsProvide guidance, direction, and management to CRAsTrack patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; assist in coordination of data management activitiesCoordinate study suppliesNegotiate contracts with vendors of clinical trial servicesReview informed consent forms, CRFs, and study related materialsPlan and participate in investigator meetingsAssist and support data query processAssure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA/ICH guidelinesEnsure the trial master file is current and maintainedCollaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trialsRequirements (Knowledge and Experience)Strong experience in clinical trial documentation and processes (protocols, CRFs, monitoring plans)Strong experience in clinical trials managementStrong experience in data management and query resolution in clinical trialsOverall knowledge of site management and monitoring proceduresGood Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines)SkillsOversee all aspects of clinical trials from initiation to closeout, ensuring timely completion within budget through effective project managementIdentify and resolve issues that arise in a timely manner during trial execution to minimize delays and maintain study integrity, employing strong problem‑solving abilitiesEffectively manage multiple tasks, deadlines, and priorities in a complex clinical trial environmentClearly convey information and expectations to cross‑functional teams, investigators, and stakeholdersEducationDegree in the life sciences field preferredContactFor more details contact Seniority levelMid‑Senior levelEmployment typeFull‑timeJob functionHealth Care Provider, Science, and ResearchIndustriesPharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care#J-18808-Ljbffr
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