Project Manager - Gen Med

Project Manager - Clinical Operations (Remote, UK) About the Role

Novotech is seeking an experienced Project Manager to lead the successful delivery of global clinical trials from study start-up through study close-out.

As the primary point of contact for sponsors, you will be responsible for the planning, execution and management of all contracted project responsibilities, ensuring studies are delivered on time, within budget and in compliance with ICH-GCP, applicable regulatory requirements and Novotech SOPs.

You will lead cross-functional project teams, oversee study operations and financial performance, proactively manage project risks, and build strong relationships with sponsors and key stakeholders throughout the project lifecycle.

• Lead the end-to-end delivery of assigned clinical studies from feasibility and site selection through study close-out.
• Determine project feasibility and provide operational input to support Business Development activities.
• Review project scope, timelines, deliverables and responsibilities to ensure successful project execution.
• Ensure all contracted services are delivered in accordance with the Project Agreement and agreed quality standards.
• Develop, maintain and monitor project plans, study timelines, risk registers, CTMS and study tracking tools.
• Identify project risks and implement effective mitigation and contingency plans.
• Coordinate global cross-functional teams including Clinical Operations, Regulatory Affairs, Medical, Biometrics, Data Management, Pharmacovigilance and Vendor Management.
• Oversee project start-up activities and ensure study teams are appropriately trained on protocol and project requirements.
• Collaborate with Resource Management to ensure projects are appropriately staffed throughout the study lifecycle.
• Lead, motivate and support internal project teams to deliver study milestones within agreed timelines.
• Delegate activities appropriately to Associate Project Managers while providing ongoing coaching and oversight.
• Monitor study progress and communicate updates, risks and key milestones to sponsors and internal leadership.
• Manage project budgets in accordance with the Master Services Agreement and Project Agreement.
• Monitor revenue forecasts, profitability and project financial performance.
• Identify scope changes and work collaboratively with Business Development to prepare and manage change orders before additional work commences.
• Escalate financial or operational risks that may impact project delivery or profitability.
• Work closely with Vendor Management to select, appoint and oversee external vendors including:
  • Central Laboratories
  • Drug Distribution providers
  • IRT/IWRS vendors
  • Other specialist clinical service providers
• Ensure vendor performance, quality and timelines meet study requirements.

• Identify and evaluate investigational sites to meet sponsor objectives.
• Partner with Clinical Operations and Regulatory teams to ensure timely ethics and regulatory submissions and approvals.
• Ensure investigational site personnel receive appropriate protocol and study training.
• Organise and participate in Investigator Meetings where required.
• Oversee study logistics to ensure investigational sites maintain appropriate study supplies.
• Monitor site activation, recruitment and retention performance.
• Develop and implement recruitment recovery plans where enrolment targets are at risk.
• Review monitoring visit reports to ensure protocol compliance, consistency of monitoring activities and timely issue resolution.
• Ensure safety reporting procedures are implemented and followed.
• Support CRAs to ensure monitoring activities, eCRF completion and query resolution are completed within sponsor timelines.
• Collaborate with Data Management to ensure data quality and study milestones are achieved.
• Work alongside Pharmacovigilance teams to coordinate safety management activities and Safety Review Committee activities where applicable.

• Ensure the Trial Master File (TMF/eTMF) is established, maintained and quality controlled throughout the study.
• Review and approve essential documents required for site activation.
• Ensure Investigational Product (IP) management complies with study protocol and ICH-GCP requirements.
• Oversee study reconciliation, archiving and close-out activities.
• Maintain inspection and audit readiness throughout the project lifecycle.
• Lead responses to audits and regulatory inspections in collaboration with cross-functional teams.

• Serve as the primary point of contact for assigned sponsors.
• Build trusted client relationships through proactive communication and delivery excellence.
• Provide regular written and verbal study updates, project reports and risk assessments.
• Lead sponsor meetings, governance meetings and project teleconferences.
• Facilitate communication between sponsors, clinical sites and internal project teams.
• Advise sponsors on local regulatory…