Global Study Manager – FSP EMEA

This is a fully remote position, open to applicants in United Kingdom, +5 more countries.

📋 Description

• Direct the operational strategy and comprehensive execution of one or more global clinical studies.

• Manage study timelines, budgets, quality, risks, and essential operational deliverables.

• Provide strategic guidance to global, cross-functional study teams and facilitate timely decision-making.

• Act as the representative for Clinical Operations within the Study Leadership Team and serve as the primary escalation point for operational challenges.

• Convert clinical development and asset strategy into well-defined study-level operational plans.

• Lead proactive identification of study risks, mitigation strategies, and issue resolution.

• Ensure thorough feasibility assessments, study planning, and operational execution.

• Offer strategic operational contributions to protocols, informed consent documents, and other crucial study materials.

• Oversee Contract Research Organizations (CROs) and other external partners, including vendor selection, performance oversight, and escalation when deliverables are at risk.

• Ensure adherence to ICH-GCP, applicable regulations, standard operating procedures (SOPs), and readiness for inspections.

• Spearhead study financial planning, forecasting, and budget management.

• Relay study progress, risks, decisions, and recommendations to senior stakeholders and governance bodies.

• Advocate for innovative approaches to clinical trial delivery, including decentralized trials, technology integration, automation, and AI-enabled methodologies.

• Participate in continuous improvement initiatives within Clinical Operations.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or a related field.

• Extensive experience in delivering global clinical studies, ideally across various phases, indications, and geographic regions.

• Proven track record of end-to-end accountability for complex global clinical trials.

• Strong experience in leading global cross-functional teams within a matrix organizational structure.

• Demonstrated ownership of study timelines, budgets, risks, quality, and operational strategies.

• Significant experience managing CROs and third-party vendors, including performance oversight and issue resolution.

• Comprehensive knowledge of ICH-GCP, global regulatory standards, and clinical development processes.

• Strong project and financial management skills.

• Ability to influence senior stakeholders and drive decision-making in complex, fast-paced environments.

• Excellent leadership, communication, negotiation, and conflict resolution abilities.

• Experience in proactively identifying and addressing risks that may affect clinical programs.

• Experience with Phase II and/or Phase III global clinical trials, adaptive or innovative trial designs, decentralized clinical trials, platform/umbrella/basket studies, technology-enabled delivery, automation, or AI/ML, as well as collaboration with investigators, external experts, and regulatory authorities is highly desirable.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday-Friday work schedule.