Senior Clinical Trial Manager

2 weeks ago

Dublin, Dublin City, Ireland Gilead Sciences Ireland UC Full time

Description

Senior Clinical Trial Manager, Clinical Operations - Dublin

The Role
The Clinical Operations team plays a crucial role at Gilead Dublin's Paediatric Center of Excellence, overseeing the management and execution of Paediatric Clinical Trials worldwide. Collaborating with Clinical Research, Medical Affairs, and other Development Operations functions, Clinical Operations ensures that all trial activities comply with SOPs, company policies and regulatory guidelines to deliver high-quality clinical data for global product registration and commercialization. The Senior Clinical Trial Manager is a key member of the Dublin team, working closely with the Clinical Program Manager to oversee global and regional clinical trials, adapt to changes, and address issues as they arise.

Key Responsibilities

  • Independently manage global studies, regional components of global Phases II-III studies, and small clinical trials.
  • Provide guidance and oversight for international clinical trials within set budgets and timelines in collaboration with CPMs.
  • Manage clinical trials budget and handle RFPs, CRO/vendor selection, and management.
  • Act as the main contact for CROs, troubleshoot issues, and guide project activities.
  • Write study protocols, reports, and regulatory documents, ensuring compliance and data integrity.
  • Contribute to TMF documentation and cross-functional reviews.
  • Offer training on study requirements to CROs, vendors, and investigators.
  • Support departmental initiatives and contribute to abstracts, presentations, and manuscripts.
  • Oversee team members, provide coaching, and conduct monitoring visits when needed.
  • Travel as necessary for the role.

Knowledge, Experience & Skills:

  • Hold a BSc or BA in a relevant scientific discipline or RN qualification.
  • Possess pertinent clinical trial experience in the pharmaceutical sector.

Gilead Core Values

  • Integrity (Doing What's Right)
  • Teamwork (Working Together)
  • Excellence (Being Your Best)
  • Accountability (Taking Personal Responsibility)
  • Inclusion (Encouraging Diversity)

About Gilead
Gilead Sciences is a research-based biopharmaceutical company committed to developing and commercializing innovative medicines that address unmet medical needs. Focusing on areas like HIV/AIDS, liver diseases, cancer, inflammation, and respiratory/cardiovascular conditions, Gilead aims to enhance patient care globally through groundbreaking discoveries.

Equal Employment Opportunity (EEO)
Gilead Sciences and its subsidiaries maintain a policy of fair and equal employment opportunities, emphasizing merit-based selection and non-discriminatory practices in all aspects of employment. Regardless of protected characteristics, Gilead ensures that all actions related to compensation, benefits, training, and other programs are handled without bias based on federal, state, or local laws.

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