Clinical Trial Manager

Description:

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.