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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior Clinical Project Manager


Reference:SCAWYY-680581 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Trials Advisor

Senior Clinical Project Manager
Our client, a pharmaceutical company based in Dublin are currently recruiting for an experienced Senior Clinical Project Managerto join their team on a permanent basis. As Senior Clinical Project 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, be strategic thinking, and have 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 organisation.

Responsibilities:

  • Lead the planning and execution of clinical trials from initiation to completion
  • Develop and manage study budgets, timelines, and resources
  • Oversee protocol development, regulatory submissions, and sites selection
  • Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements
  • Act as the primary point of contact for internal and external stakeholders
  • Manage and mentor cross-functional teams, ensuring efficient communication and collaboration
  • Monitor study progress, identify risks, and implement mitigation strategies
  • Review and approve study-related documentation, including investigator brochures, informed consent forms, and clinical study reports
  • Provide strategic input into trial design, feasibility assessment, and operational strategy
  • Conduct regular project status updates and present findings to senior management

Requirements:
  • Bachelor's or Master’s degree in Life Sciences, Pharmacy, or a related field
  • Minimum of 5-7 years of experience in clinical trial management within the pharmaceutical, biotech, or CRO industry
  • Strong knowledge of clinical trial regulations (FDA, EMA, ICH-GCP)
  • Proven track record of managing multi-center, global clinical trials
  • Excellent project management, leadership, and problem-solving skills
  • Strong interpersonal and communication abilities to liaise with various stakeholders
  • Proficiency in using different EDC system
  • Ability to work in a fast-paced, deadline-driven environment
  • Willingness to travel as needed
For more information, please contact Sinéad Cullen on +353879500821 or [email protected]