Country Study Manager (Local Delivery Lead) in London

This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following:

• Leadership & Team Management: Provides matrix leadership and comprehensive project management to the local study team. Coordinates cross-functional experts, vendor staff, and external clinical site personnel from study planning through execution. Responsible for fostering collaboration, evaluating team performance, and delivering feedback to line management when necessary.
• Operational Oversight & Communication: Acts as the primary operational link between central and local study teams, medical, and regulatory staff. Facilitates alignment on feasibility, site selection, and local requirements. Ensures that study systems (e.g., TMF) are complete and accurate, and progress is effectively reported to stakeholders.
• Delivery & Quality Assurance: Oversees that critical study timelines, recruitment targets, patient recruitment cycle times, data integrity, and audit quality are forecasted, monitored, and achieved. Provides troubleshooting and problem resolution support, identifies risks, and escalates issues as needed to maintain productive, efficient study delivery.
• Compliance & Documentation: Ensures all regulatory requirements are met by preparing and coordinating submissions of Clinical Study Applications and local Informed Consent Forms to Regulatory Authorities (RA) and Ethics Committees (ECs). Maintains ongoing communication and assists with audits and inspections of local clinical operations and study sites.
• Budget, Contracts & Monitoring: Estimates, tracks, and delivers against local study budgets. Advises on contract development with sites, CROs, and vendors, participates in negotiations, reviews and approves monitoring visit reports, and verifies that monitoring activities are completed according to plan. Supports financial and contractual compliance throughout the study lifecycle.
• Continuous Learning: Acquires and maintains knowledge related to study compounds, protocols, disease area pathology, local treatment guidelines, and healthcare system requirements. Continuously develops skills in GCP, SOPs, monitoring, site and project management, and shares best practices.
• Working Model and Location: This role is based in the United Kingdom. The role follows a hybrid working model. You will attend the office for collaboration and key meetings. You will work remotely for focused tasks as agreed with your manager.

Qualifications:

• Bachelor's degree or equivalent in a science-related field (e.g., life sciences, medicine, clinical research, pharmacy).
• Solid operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug/vaccine development process.
• Demonstrated strength in problem-solving, negotiation, conflict resolution, and stakeholder management in a matrix environment.
• Excellent communication and leadership skills, with the ability to collaborate effectively.
• Excellent planning, organisational, and project-management skills, with the ability to operate effectively in a dynamic, fast-changing environment.
• Strong knowledge of GCP/ICH and country-specific regulations.

Preferred Qualifications & Skills (not required, but a plus):

• Experience in oncology and/or respiratory therapeutic areas.
• Ability to lead cross-functional teams and manage external partnerships.
• Master of Science, PhD or equivalent coupled with previous project management experience.

Benefits:

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.