Senior Clinical Trial Manager
hace 6 días
At Parexel FSP people make the difference. We have a crucial mission: to prevent and cure disease by delivering important new medicines and therapies to patients in need. We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world.Our employees have the opportunity to do meaningful things globally while we support them locally in environments full of challenge, collaboration, flexibility and industry-leading growth potential.Parexel FSPis recruiting for aClinical Trial Managerbased inSpain. Home based role. Dedicated to a single sponsor.You will will manage individual clinical trials and/or programs as part of the Clinical Trial Working Group.We will offer you exceptional financial rewards, training, and development.Expect exciting career challenges, but with a healthy work-life balance. We value your well-being as much as that of our patients.Tasks on the roleManage external vendors and contract research organizationsPrepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory ManualCoordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documentsAssist with protocol development and study report completionManage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocolsProvide guidance, direction, and management to CRAsTrack patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and 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 and ICH guidelinesEnsures trial master file is current and maintainedCollaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials>RequirementsKnowledge and Experience:Strong experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans).Strong experience in clinical trials management (at least 6 years).Strong experience of 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 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 environmentClearly convey information and expectations to cross-functional teams, investigators, and stakeholders.EducationDegree in the life sciences field preferredFor more details contact
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