Global Study Manager – FSP, PACT/MAP experience

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

📋 Description

• Execute clinical operational tasks from the initiation of studies to their archiving.

• Develop accelerated delivery strategies aimed at achieving upper-quartile performance and meet or exceed targets with a focus on quality.

• Collaborate closely with the Global Study Lead to ensure comprehensive clinical study delivery.

• Direct the operational execution of global clinical trials, ensuring timely completion, adherence to quality and budget constraints, company standards, and scientific guidelines.

• Facilitate swift decision-making and guide study teams to meet overall study objectives.

• Conduct study initiation meetings, create clinical study activity plans, devise study delivery plans, produce TMF quality strategy documents, oversee DCT setups, vendor management plans, establish investigator/CRA meeting arrangements and training, track recruitment, monitor budgets, manage eTMF filing, and implement safety management strategies.

• Identify, supervise, and alleviate study-related risks.

• Manage communications with stakeholders concerning study progress, expectations, potential risks, and issues.

• Operate within the confines of study budgets.

• Lead empowered matrix teams effectively.

• Offer operational insights into protocols, informed consent documents, and other critical study materials.

• Facilitate and lead investigator and study-related meetings.

• Drive quality initiatives focusing on protocol adherence and ongoing inspection readiness.

• Oversee the activities of participating countries.

⛳️ Requirements

• A Bachelor’s degree in life sciences or a related field is required.

• A minimum of 5+ years of relevant experience in global study management is essential.

• Previous experience with PACT/MAP is preferred.

• Comprehensive background in clinical research, encompassing study management, monitoring, and data management.

• Experience managing end-to-end global clinical studies across NA, EMEA, APAC, LATAM, China, and Japan; experience in Africa is advantageous.

• Demonstrated experience from study feasibility to Clinical Study Report (CSR) completion.

• At least Phase II and Phase III experience is required; experience in Phase I and Phase IV is a plus.

• Proven leadership experience across cross-functional teams and the capacity to guide both internal and external meetings.

• Ability to contribute effectively to clinical protocols, informed consent forms, and study plans.

• Proficiency in clinical study risk management and clinical systems.

• Strong experience in clinical budget management.

• Solid vendor management experience, particularly with CROs.

• Familiarity with competent authority inspections, including FDA, EMA, MHRA, and PMDA; involvement in pivotal drug-registration studies is beneficial.

• Proficient in English, with the capability to negotiate complex topics and provide clear status updates to upper management.

• Exceptional stakeholder management skills along with strong oral and written communication abilities.

• Excellent interpersonal skills.

• Leadership qualities that foster motivation and empowerment within teams.

• A robust understanding of clinical studies, drug development, sample management, related processes, quality standards, ICH/GCP guidelines, and SOPs.

• Good project management abilities, including scope, budget, timelines, resource planning and management, and relevant tools.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.