Global Study Manager – 6-month contract

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Lead and manage the execution of global clinical trials, from developing sourcing strategies and study specifications to study initiation, database release, inspection readiness, and final closure.

• Provide oversight of quality and coordinate operations at the regional and country levels, including Study Operational Managers, vendors, and pCROs.

• Guide operational teams in establishing recruitment targets and achieving delivery milestones.

• Act as the operational sub-team representative within the core study team.

• Collaborate with the Clinical Study Team Lead to shape operational strategies and facilitate decision-making.

• Oversee and mentor Study Operational Managers and potentially other Global Study Managers.

• Create, review, and authorize plans for study start-up, monitoring, recruitment, training, and other study-level activities.

• Manage drug supply and the setup of interactive randomization systems.

• Handle vendor oversight, escalations, contracts, invoices, purchase orders, and budget management.

• Evaluate feasibility outputs, approve study sites, and review site activation strategies.

• Ensure compliance with Trial Master File setup and study documentation requirements.

• Organize training for studies and protocols, as well as global investigator meetings.

• Track study delivery, metrics, analytics, risks, and mitigation strategies.

• Lead activities related to inspection readiness and site preparedness.

• Collaborate with data management, clinical teams, CROs, pCROs, vendors, and site contracting organizations.

• Analyze enrollment figures, discontinuations, protocol deviations, data reports, and dashboards.

• Offer operational insights into protocol design and clinical trial budgeting.

• Act as a technical subject matter expert regarding study management systems and processes.

⛳️ Requirements

• Bachelor’s degree in Science or Arts with at least 7 years of relevant operational clinical trial experience is required.

• Master’s degree in Science or Business Administration with a minimum of 6 years of relevant operational clinical trial experience is required.

• A scientific or technical degree is preferred.

• Comprehensive understanding of clinical trial methodology.

• Experience in clinical research and/or study management.

• Proven experience in study management or leadership roles.

• Experience overseeing CROs and vendors.

• Proficient in managing per-subject costs, vendor and ancillary expenses, monitoring cost projections, and expenditures.

• Extensive knowledge of study management processes and deliverables.

• Familiarity with Good Clinical Practices (GCPs), monitoring, clinical operations, and regulatory processes.

• Proficient in written and spoken English is essential.

• Willingness to work outside standard business hours when necessary to support global trials or initiatives.

• Ability to travel as required, including to investigator meetings, vendor kick-off and reset meetings, and internal global or department-level client meetings.

🏝️ Benefits

• 6-month contract.

• Full-time employment.

• Opportunity to work remotely from London, United Kingdom.

• Chance to contribute to therapies that enhance patient outcomes and improve global health.