Clinical Trial Lead

Overview
Global technical recruiter hiring top talent for innovative Biotech/Medtech/Pharma companies.

Clinical Trial Lead, Biopharma
Our client, a Biopharma company, seeks a Clinical Trial Lead working as part of the Clinical Operations team, collaborating with internal functions (Data Management, Clinical Research, QA, Regulatory Affairs, etc.) and external CROs and vendors to provide oversight and guidance.

This role is based in Ireland with flexibility to work primarily from a home office, with some Dublin office presence and travel as required.

The Clinical Trial Lead will lead site management activities and support the Lead Clinical Project Manager (CPM) on Phase II and III trials across the UK, EU, and US, serving as the primary day-to-day contact for CRO counterparts (CTMs, CRAs) and site staff, and supporting the Lead CPM as needed.

The successful candidate will lead and coordinate all aspects of site management—from feasibility and site identification through to close-out—including site selection, initiation, monitoring, and issue resolution in close partnership with the CRO.

Responsibilities

Review CRA visit reports to ensure monitoring activities are conducted per the monitoring plan.

Monitor site performance metrics (e.g., patient screening/recruitment, protocol deviations, DM queries) and help identify at-risk sites.

Support timely resolution of site-level issues through proactive communication and follow-up.

Ensure site compliance and performance through close collaboration with CRAs and site personnel.

Oversee adherence to protocol, regulatory requirements, and quality standards at the site level.

Track actual vs planned patient recruitment, report variances, and implement contingencies in consultation with senior management.

Monitor and report clinical study metrics and KPIs to ensure timeline and deliverable compliance, escalating unresolved issues to the CPM as appropriate.

Support Lead CPM in planning and execution of operational meetings, CRO/vendor kick-offs, Investigator Meetings, CRA trainings, and site visits (selection, initiation, monitoring, oversight).

Assist in preparing and maintaining essential study documents (protocols, ICFs, monitoring plans, trial management plans).

Support the implementation of quality, audit, and risk management plans; ensure corrective actions from audits are completed.

Ensure all trial activities comply with ICH-GCP, FDA, EMA, MHRA, and local regulatory guidelines.

Support inspection readiness efforts and contribute to clinical audits or regulatory inspections as required.

Provide guidance and mentorship to clinical operations staff and act as a resource on site-related matters.

Requirements

Bachelor’s degree in life sciences, nursing, pharmacy, or a related field.

5 years of experience in clinical research progressing from CRA to CRA II, Senior CRA/Lead CRA, or equivalent, with progression to Clinical Trial Manager/Clinical Trial Lead.

Direct experience managing Phase II and III trials across the UK, EU, and US is an advantage.

Demonstrated ability to manage multiple sites and vendors in a global clinical environment.

Proficient with clinical trial systems such as CTMS, EDC, IRT/IWRS, eCOA, and eTMF.

Strong knowledge of ICH-GCP and relevant regulatory frameworks (FDA, EMA, MHRA).

Proven ability to work effectively within a multi-cultural and geographically diverse cross-functional team.

Excellent leadership, organizational, and interpersonal skills.

Fluent in English (spoken and written).

Some international travel will be required (mainly the UK, Europe, US).

For further details, please contact Larry at +353 1 – 2302400 or larry@rftgroup.ie .

The RFT Group , BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie

Details

Seniority level : Mid-Senior level

Employment type : Full-time

Job function : Science, Research, and Project Management

Industries : Biotechnology Research, Research Services, and Pharmaceutical Manufacturing

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