Associate Director, Clinical Operations Lead
FSP Model | UK Remote
An exciting opportunity has arisen for an experienced Associate Director, Clinical Operations Lead to join a leading global pharmaceutical organisation via an FSP (Functional Service Provider) model. This is a UK-based, fully remote role, supporting complex global clinical studies and/or programs.
Role Overview
You will be accountable for the operational strategy, end-to-end delivery, and budget management of assigned clinical studies and/or programs. The role involves leading complex global trials with minimal oversight, working in a matrix environment with cross-functional internal teams and external partners, and contributing to broader clinical development planning within the therapeutic area.
Key Responsibilities
* Develop and implement clinical operations strategies, study management plans, and supporting documentation to drive efficiency and quality across complex studies
* Provide early operational input into Clinical Development Plans (CDPs) and study outlines
* Lead end-to-end management of global clinical trials, from protocol development through CSR completion and TMF archiving
* Oversee study timelines, budgets, feasibility, country strategy, enrolment plans, risk mitigation, and regulatory/GCP compliance
* Lead and coordinate cross-functional study teams in a matrix environment
* Manage vendor and CRO selection, oversight, performance management, and issue escalation
* Act as the primary point of contact for study-related matters internally and externally (e.g. vendors)
* Forecast, manage, and report on study budgets and key performance metrics
* Support audits and inspections and lead resolution of findings
* Maintain up-to-date knowledge of the therapeutic area, product candidates, clinical practice, competitors, and regulatory requirements
* Contribute to process improvement initiatives, SOP development, and cross-functional working groups
* Provide functional leadership, mentorship, and advisory support to junior clinical operations staff
* Where accountable for multiple studies or programs, ensure appropriate delegation, inter-program efficiencies, and application of learnings
Essential Requirements
* Minimum of 10 years’ experience in clinical research within the pharmaceutical or biotech industry
* Proven experience leading large and/or complex global clinical trials
* Strong understanding of the end-to-end drug development and clinical trial process
* Demonstrated expertise in budget forecasting and financial management
* Experience leading and influencing teams in a matrix environment
* Thorough knowledge of ICH-GCP and global regulatory requirements
* Previous experience in FSP or sponsor-dedicated models is highly desirable
Location & Working Model
* UK-based
* Fully remote
* FSP model, embedded with a global pharmaceutical client