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Senior Clinical Project Manager
3 weeks ago
Senior Clinical Project ManagerOur client, a pharmaceutical company based in Dublin, is currently recruiting for an experienced Senior Clinical Project Manager to join their team on a permanent basis.
As Senior Clinical Project Manager, you will be responsible for the planning, execution, and management of clinical trials, ensuring compliance with regulatory requirements, budget, and timelines.
You will have strong leadership skills, strategic thinking, and the ability to oversee the activity of different vendors, such as CROs and laboratories.
Clinical trial management in the therapeutic areas of Gastrointestinal (GI) diseases and/or Oncology is highly desirable.
This is an excellent opportunity to work directly with a sponsor organization.
Responsibilities: Lead the planning and execution of clinical trials from initiation to completionDevelop and manage study budgets, timelines, and resourcesOversee protocol development, regulatory submissions, and site selectionEnsure adherence to Good Clinical Practice (GCP), ICH guidelines, and regulatory requirementsAct as the primary point of contact for internal and external stakeholdersManage and mentor cross-functional teams, ensuring efficient communication and collaborationMonitor study progress, identify risks, and implement mitigation strategiesReview and approve study-related documentation, including investigator brochures, informed consent forms, and clinical study reportsProvide strategic input into trial design, feasibility assessment, and operational strategyConduct regular project status updates and present findings to senior management Requirements: Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related fieldMinimum of 5-7 years of experience in clinical trial management within the pharmaceutical, biotech, or CRO industryStrong knowledge of clinical trial regulations (FDA, EMA, ICH-GCP)Proven track record of managing multi-center, global clinical trialsExcellent project management, leadership, and problem-solving skillsStrong interpersonal and communication abilities to liaise with various stakeholdersProficiency in using different EDC systemsAbility to work in a fast-paced, deadline-driven environmentWillingness to travel as neededFor more information, please contact Sinéad Cullen on or ******
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