Global Project Manager

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

📋 Description

• Lead, manage, and coordinate the operational facets of global and multi-regional clinical projects from the initial protocol concept to the completion of the final clinical study report.

• Ensure that client objectives regarding time, cost, quality, client satisfaction, operational delivery, ICH-GCP compliance, regulatory standards, and adherence to SOPs are met.

• Develop and implement comprehensive global project plans, including Integrated Quality Management Plans and Risk Management Plans.

• Confirm that site facilities and staff are adequately prepared to meet the demands of global clinical trials.

• Review and provide feedback on clinical trial protocols and align the clinical monitoring team with protocol-related activities.

• Review, authorize, and implement strategies, policies, and standard operating procedures.

• Participate in investigator meetings, governance committees, and other clinical research meetings as necessary.

• Create and support annual budgets, billability levels, revenue goals, and expense targets.

• Ensure quality control and standardization of CNS rating scales through training and monitoring of raters.

• Develop proposals in response to pharmaceutical and biotech RFPs; assist in creating bid-defense presentations and participate in bid defenses.

• Act as the main operational liaison with sponsors concerning study execution, timelines, quality, risks, financial performance, and budgets.

• Allocate study resources, including outsourcing and vendor identification, and manage resource requirements across global regions.

• Supervise global feasibility, regulatory submissions, country/site activation, start-up metrics, and site greenlight status.

• Provide strategic leadership and direction to the Clinical Manager and clinical monitoring team.

• Analyze monitoring trends, non-compliance issues, and critical deviations at sites.

• Develop project documentation and ensure timely delivery of study plans by cross-functional leads.

• Track, manage, and report on project and overall trial budgets.

• Oversee site selection, initiation, and start-up processes.

• Supervise interim study conduct, recruitment and enrollment, safety issues, SAE tracking, study drug supply, and review monitoring reports.

• Identify resource or progress gaps, drive risk management efforts, and create corrective action plans.

• Communicate progress of the study and key milestones, including FPI, LPV, DBL, CSR, and TMF metrics.

• Coordinate study close-out, resolve data queries, and lock the database.

• Manage document storage and maintain readiness for internal quality audits and regulatory inspections.

• Execute additional duties as assigned.

⛳️ Requirements

• A bachelor's degree is required; a Master's degree is preferred in Life Sciences, Pharmacy, Nursing, or a related scientific discipline.

• Approximately 5 to 7 years of direct experience in clinical research project management within a CRO or pharmaceutical setting.

• Experience in project management and the development of study procedures and processes.

• Proven history of managing complex, multi-region, global clinical trials across at least two regions simultaneously.

• Extensive operational experience leading CNS trials, such as those for Alzheimer’s, Parkinson’s, Epilepsy, Depression, Schizophrenia, Multiple Sclerosis, or rare neurodevelopmental disorders.

• Strong understanding of CNS endpoints, challenges related to rater variability, and strategies to mitigate the placebo effect in psychiatric and neurological trials.

• Demonstrated knowledge of the entire drug development process, including study initiation, clinical monitoring, Data Management, biostatistical output, drug safety, regulatory issues, and report generation.

• Proficiency in ICH/GCP guidelines, FDA, EMA, local regulations, CTMS, EDC, eTMF, and project management tools like MS Project.

• Excellent verbal and written communication, organizational, time-management, customer service, and interpersonal skills.

🏝️ Benefits

• Global travel may be required based on study needs.

• Opportunities for professional development and involvement in process improvement initiatives.