Clinical Trials Manager

Job Title: Clinical Trials Manager (12-Month Contract)
Location: Dublin
Contract Type: Fixed-Term Contract (12 Months)
Department: Clinical Operations
Reports To: Director of Clinical Operations / Senior Clinical Program Manager

Position Summary
We are seeking an experienced Clinical Trials Manager to oversee the planning, execution, and delivery of clinical studies within our pharmaceutical development portfolio. The successful candidate will be responsible for managing clinical trial operations from study start-up through closeout, ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), company SOPs, and project timelines.

This 12-month contract role requires strong project management capabilities, stakeholder management skills, and experience working with CROs, investigators, and cross-functional teams in a fast-paced pharmaceutical environment.

Key Responsibilities

• Clinical Trial Management
• Lead the operational planning, execution, and oversight of assigned clinical trials.
• Develop and manage study timelines, budgets, risks, and operational plans.
• Ensure studies are conducted in compliance with protocol, ICH-GCP guidelines, regulatory requirements, and company SOPs.
• Monitor study progress, identify operational challenges, and implement mitigation strategies.
• Coordinate study start-up, site activation, recruitment, monitoring, and closeout activities.
• Vendor and CRO Oversight
• Manage relationships with Contract Research Organizations (CROs), central laboratories, and other clinical vendors.
• Review vendor performance against agreed deliverables and key performance indicators.
• Facilitate regular governance meetings and issue resolution processes.
• Cross-Functional Collaboration
• Work closely with Clinical Development, Medical Affairs, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, Quality Assurance, and Supply Chain teams.
• Ensure alignment of study objectives, timelines, and deliverables across all stakeholders.
• Provide regular updates to project teams and senior management.
• Site and Investigator Management
• Support site selection, feasibility assessments, and investigator engagement activities.
• Review site performance metrics and implement strategies to improve recruitment and retention.
• Address site-related issues and ensure timely resolution.
• Compliance and Quality
• Ensure inspection readiness throughout the study lifecycle.
• Support audits and regulatory inspections as required.
• Review and approve key study documentation, including monitoring plans, study management plans, and trial master file content.
• Maintain accurate and complete trial documentation
• Reporting and Communication
• Prepare and present study status reports to internal stakeholders and governance committees.
• Escalate significant risks, deviations, and timeline impacts appropriately.
• Contribute to lessons learned activities and process improvement initiatives.

Qualifications and Experience
Essential

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline.
• Minimum 5 years' experience in clinical research within the pharmaceutical, biotechnology, or CRO industry.
• Proven experience managing Phase I–IV clinical trials
• Strong knowledge of ICH-GCP, FDA, EMA, and applicable regulatory requirements.
• Experience managing CROs and external vendors.
• Demonstrated project management and budget management experience.
• Excellent communication, stakeholder management, and problem-solving skills.
• Proficiency with clinical trial systems and Microsoft Office applications.
• Advanced degree (MSc, PharmD, PhD, or equivalent).
• Project Management certification (PMP, PRINCE2, or equivalent).
• Experience in oncology, rare diseases, immunology, or other relevant therapeutic areas.
• Experience with global or multi-country clinical studies.
• Clinical trial leadership
• Project and timeline management
• Vendor oversight and governance
• Risk management
• Regulatory and GCP compliance
• Budget management
• Stakeholder engagement
• Decision-making and problem-solving
• Attention to detail
• Effective communication and influencing skills

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