Senior Clinical Project Manager

Role: Senior Clinical Project Manager

Location: Ireland

Compensation: £75,000-£85,000

The Company:

My Client is a highly innovative, clinical-stage biotechnology company focused on developing transformative therapies for patients with underserved and rare medical conditions. As a lean, agile organisation, they offer the opportunity to work closely with senior leadership, influence development strategy, and make a visible impact on the progression of our clinical pipeline.

This is an exciting opportunity for an experienced Clinical Project Manager to take ownership of clinical trial delivery across international studies, managing external partners while helping shape the future growth of a rapidly evolving biotech.

As Senior Clinical Project Manager, you will be responsible for the operational leadership of clinical studies from start-up through close-out. Working within a small, collaborative team, you will oversee CRO performance, vendor management, study budgets, timelines, and risk mitigation activities while ensuring the highest standards of quality, compliance, and execution.

This role would suit a proactive individual who thrives in a fast-paced biotech environment and enjoys taking broad ownership of clinical operations rather than working within a highly siloed structure.

Key Responsibilities:

• Lead the operational management of global clinical studies from initiation through database lock and study close-out.
• Oversee and manage CROs and external vendors, ensuring delivery against agreed timelines, budgets, quality standards, and study milestones.
• Support CRO selection, vendor evaluation, and contract implementation where required.
• Monitor study progress through KPI tracking, risk assessments, and performance reviews, implementing corrective and preventive actions when necessary.
• Collaborate closely with Clinical Development and Medical teams to support investigator identification, site feasibility, and site network development.
• Contribute to protocol review and provide operational input into study design and execution strategies.
• Coordinate Investigator Meetings and support site engagement activities.
• Ensure Investigational Medicinal Product (IMP) availability throughout study conduct.
• Act as the primary operational point of contact for CRO project teams, CRAs, and internal stakeholders.
• Own study budget tracking, forecasting, reconciliation, and change order management.
• Identify operational risks and proactively implement mitigation plans to maintain study objectives.
• Ensure Trial Master File (TMF) quality, completeness, and inspection readiness.
• Maintain compliance with ICH-GCP, company SOPs, regulatory requirements, and industry best practices.

Key Requirements:

• Bachelor's or Master's degree in Life Sciences, Biotechnology, Pharmacology, or a related scientific discipline.
• Minimum 5 years' experience in Clinical Project Management, Clinical Operations, or a comparable role within biotechnology, pharmaceutical, or CRO environments.
• Proven experience managing outsourced clinical studies through CRO partnerships.
• Strong understanding of ICH-GCP guidelines and global clinical trial regulations.
• Experience managing study budgets, forecasts, vendor contracts, and change orders.
• Demonstrated ability to analyse study performance metrics and drive operational improvements.
• Strong stakeholder management skills with the confidence to influence both internal and external teams.
• Excellent organisational, communication, and project leadership capabilities.
• Ability to work independently and take ownership within a small-company environment.

Highly Desirable

• Experience within rare disease, dermatology, orphan drug development, or speciality therapeutics.
• Experience supporting Phase I-III international clinical trials.
• Previous experience within a small or emerging biotech environment.
• Exposure to regulatory inspections and TMF audits.

Why Join?

• Join a growing biotech where your contribution will directly influence clinical strategy and study success.
• Broad exposure across clinical development, operations, and cross-functional decision-making.
• Opportunity to work closely with executive leadership and key development partners.
• Flexible working environment with significant autonomy.
• Competitive compensation package, bonus potential, and long-term growth opportunity.