UK Home‑Based Clinical Trial Manager

Meeveem Limited; Reading; Hybrid; GBP 70,000 - 95,000; Full time

Job summary

Syneos Health is seeking a Single Sponsor Clinical Trial Manager / Local Study Manager for the UK home-based role within commuting distance of Reading. You will lead study set-up, regulatory submissions, site management, and data integrity, coordinating with CRAs and Clin Ops Specialists to meet milestones.

You will drive risk-based monitoring, maintain CTMS/EDC dashboards, and ensure compliance with GCP. Strong leadership and communication are essential for success.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Demonstrated ability to lead and align teams in the achievement of project milestones
• Demonstrates capability of working in an international environment
• Demonstrates expertise in site management and monitoring
• Preferred experience with risk-based monitoring
• Demonstrates understanding of clinical trial management financial principles and budget management
• Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements
• Must demonstrate good computer skills
• Good communication, presentation and interpersonal skills among project team and with sites
• Strong conflict resolution skills
• Demonstrates ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach

Responsibilities

• Responsible for study set-up: prepares and completes UK regulatory submission: initial and amendments including regulatory package documents creation and customisation
• Responsible for site management oversight, clinical monitoring with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity
• Oversees site interactions from feasibility through site closeout
• May identify data and process risks and mitigation related to the Risk Assessment and Categorization Tool (RACT)
• Reviews the study scope of work, budget and protocol content for contracted obligations
• Uses data and metrics to identify risks to trial management deliverables
• Escalates risks to global manager when outside contracted scope
• Proposes risk mitigations and uses strategic thinking
• Participates and presents in key meetings such as Kick Off Meeting
• Interacts with principal investigators and site staff by phone or in person
• Coordinates delivery handoffs to meet site activation and enrollment milestones
• Develops and maintains clinical study tools and templates, CTMS dashboards, and conducts user testing
• Coordinates study team training on protocol specifics and data plans
• Manages resourcing for CRAs and site assignments
• Ensures quality of monitoring and data, using approved systems and tracking tools
• Reviews CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS dashboards for timely execution
• Participates in development of the study risk assessment plan
• Ensures site monitoring documentation reflects activities and risks
• Interacts with client and other functions to provide status updates and solutions
• Supports QA readiness and adherence to regulatory requirements
• Oversees performance of CRAs and Clin Ops Specialists and resolves issues
• Provides feedback on staff performance and handles larger, complex trials

Skills

Leadership

Site management

Clinical monitoring

Budget management

GCP/ICH knowledge

Communication

Problem solving

Risk management

Education

Bachelor’s degree or RN

Tools

CTMS

EDC

eDiary

ePROs

TMF

IVRS/IWRS

Job description

Syneos Health is seeking a Single Sponsor Clinical Trial Manager / Local Study Manager for the UK home-based role within commuting distance of Reading. You will lead study set-up, regulatory submissions, site management, and data integrity, coordinating with CRAs and Clin Ops Specialists to meet milestones.

You will drive risk-based monitoring, maintain CTMS/EDC dashboards, and ensure compliance with GCP. Strong leadership and communication are essential for success.