Clinical Trial Lead, Biopharma
Our client, a Biopharma company, now seek a Clinical Trial Lead working as part of the Clinical Operations team and with internal functions (e.g. Data Management, Clinical Research, QA, Reg Affairs, etc.) and working externally providing support for oversight of CROs and other vendors.
This hire will be based in the UK or Ireland and have flexibility to work majority of time from their home office, with some office presence and travel as required.
This hire will lead site management activities and support the Lead Clinical Project Manager (CPM) on Phase II and III Clinical trials across the UK, EU, US, etc. Serving as the primary day-to-day contact for their CRO counterpart (i.e. CTMs, CRAs), and clinical site staff; and supporting the Lead CPM as required.
The successful candidate will lead and coordinate all aspects of site management, from feasibility and site identification through to close-out, including selection, initiation, monitoring, and issue resolution, in close partnership with the CRO.
The ideal candidate will have 5 years Clinical Research experience; progressing from CRA I, II, Senior CRA / Lead CRA, or CTM. Clinical Trial Management experience is preferred, on late-stage Clinical trials (i.e. II and III), to ICH-GCP, MHRA, EMA and FDA guidelines.
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 etc.) 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 the planning and execution of operational meetings, CRO/vendor kick-offs, Investigator Meetings, CRA trainings, and site visits (selection, initiation, motivational and monitoring oversight).
Assist in preparing and maintaining essential study documents (e.g., 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 to experienced Clinical Trial Manager / Clinical Trial Lead or equivalent role.
Direct experience managing Phase II and III trials across the UK, EU, US, and UK 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 successfully achieve results 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 contactLarry on +353 1 – 2302400 /
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
