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Clinical Trial Specialist - UK (Remote) - FSP - Job Opportunity at Parexel

London, United Kingdom
Full-time
Mid-level
Posted: June 19, 2025
Remote
£35,000 - £45,000 per year based on the mid-level experience requirements, UK market rates for clinical research professionals, and Parexel's position as a leading global CRO. The remote nature and FSP model typically command premium compensation, with potential for performance-based increases and comprehensive benefits packages.

Benefits

Comprehensive company-sponsored events fostering professional networking and team building opportunities
Long-term job security with substantial career advancement prospects in a stable FSP environment
Opportunity to work on vital clinical studies for leading global biotechs and top 50 pharmaceutical companies
Professional development opportunities across related departments within Parexel's diverse organizational structure

Key Responsibilities

Drive strategic study operations from feasibility through close-out, ensuring optimal site performance and regulatory compliance across all phases of clinical development
Lead comprehensive essential document management systems, establishing robust documentation frameworks that support regulatory submissions and audit readiness
Collaborate with senior leadership to develop and maintain critical study documentation, contributing to protocol development and strategic planning initiatives
Oversee Trial Master File integrity and compliance, ensuring seamless regulatory audit preparation and maintaining industry-leading documentation standards
Facilitate cross-functional team coordination through strategic meeting management, maintaining comprehensive risk assessment and decision-making frameworks
Execute independent site monitoring and co-monitoring visits, providing critical oversight that directly impacts patient safety and data integrity
Provide rapid-response solutions for internal and external quality assurance findings, demonstrating proactive problem-solving capabilities
Manage vendor relationships and third-party deliverables, ensuring cost-effective operations and maintaining high-performance standards across contracted services
Lead comprehensive study performance tracking and site oversight, implementing metrics-driven approaches to optimize clinical trial efficiency
Drive data quality initiatives through systematic review processes, query resolution, and protocol deviation management that directly impacts regulatory approval timelines
Contribute to departmental strategic initiatives and collaborative protocol development efforts that shape future clinical development programs

Requirements

Education

Bachelor's, nursing degree or equivalent required, science preferred

Experience

At least 2 years of experience (3yrs preferred) in clinical studies (Pharmaceutical industry experience preferred)

Required Skills

Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures Understanding of study phases and general knowledge of how they apply to clinical development Demonstrated ability to work independently and in a team environment Advanced knowledge of Word, Excel, and PowerPoint Working knowledge of electronic Systems including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet, SharePoint, etc.) Knowledge of the principles and practices of computer applications in database management Strong verbal and written communication skills required Previous site monitoring or study coordinator experience is preferred
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Sauge AI Market Intelligence

Industry Trends

The clinical research industry is experiencing unprecedented growth driven by increased biotech funding and accelerated regulatory pathways, with CROs like Parexel expanding their Functional Service Provider (FSP) models to meet rising demand for flexible, dedicated clinical trial support. This trend reflects the pharmaceutical industry's shift toward outsourcing specialized clinical operations to maintain agility while managing complex regulatory requirements. Digital transformation in clinical trials is reshaping the role of Clinical Trial Specialists, with increased emphasis on electronic systems proficiency and data management capabilities. The integration of AI-driven platforms and remote monitoring technologies is creating new opportunities for professionals who can bridge traditional clinical research expertise with modern digital workflows. The post-COVID clinical research landscape has permanently elevated the importance of remote work capabilities and decentralized trial management, making remote Clinical Trial Specialist positions increasingly valuable and competitive in the UK market. Regulatory harmonization across global markets is creating demand for Clinical Trial Specialists who understand international GCP standards and can support multi-regional studies, particularly for biotechnology companies seeking expedited pathways to market approval.

Role Significance

Typically operates within a cross-functional team of 8-12 professionals including Clinical Trial Managers, Data Managers, and Regulatory Affairs specialists, with direct collaboration with 3-5 vendor partners and oversight of 2-4 clinical sites per study.
This mid-level position serves as a critical bridge between operational execution and strategic oversight, with significant autonomy in managing study documentation and vendor relationships. The role carries substantial responsibility for regulatory compliance and quality assurance, indicating strong influence on trial outcomes and patient safety.

Key Projects

Multi-phase clinical trials for novel therapeutic compounds in oncology, cardiovascular, and rare disease indications Complex regulatory submission support including IND and NDA documentation preparation International clinical development programs requiring coordination across multiple regulatory jurisdictions Post-market surveillance studies and real-world evidence generation initiatives

Success Factors

Developing deep expertise in regulatory compliance and GCP standards while maintaining awareness of evolving guidelines and industry best practices that directly impact trial success and patient safety Building strong vendor management and cross-functional collaboration skills that enable effective coordination of complex clinical operations across multiple stakeholders and geographic regions Mastering electronic clinical trial systems and data management platforms to drive efficiency and accuracy in an increasingly digital clinical research environment Cultivating proactive problem-solving capabilities and risk management expertise that can identify and address potential issues before they impact trial timelines or regulatory compliance

Market Demand

High demand driven by expanding clinical research activities, increased outsourcing to CROs, and the growing complexity of regulatory requirements. The FSP model is particularly sought after by pharmaceutical companies seeking dedicated resources, creating strong job security and career advancement opportunities.

Important Skills

Critical Skills

GCP regulatory knowledge forms the foundation of all clinical trial activities and is essential for ensuring patient safety, data integrity, and regulatory compliance. This expertise directly impacts the company's ability to successfully navigate complex regulatory requirements and maintain its reputation with pharmaceutical clients. Electronic systems proficiency in platforms like Veeva Vault and CTMS is increasingly critical as the industry moves toward fully digital trial management, making this skill set essential for efficiency and competitive advantage in clinical operations. Vendor management capabilities are crucial for controlling costs and ensuring quality deliverables in an outsourced clinical research environment, directly impacting trial timelines and budget management.

Beneficial Skills

Advanced data analysis skills using statistical software would enhance career prospects in an increasingly data-driven clinical research environment Project management certification (PMP) would provide valuable credentials for advancement to senior management roles Additional therapeutic area expertise in high-growth sectors like oncology or rare diseases would increase market value and specialization opportunities Regulatory writing skills would open opportunities in medical communications and regulatory affairs career tracks

Unique Aspects

Dedicated single-sponsor FSP model providing exceptional job security and deep therapeutic area expertise development opportunities
Direct involvement in supporting trials for breakthrough therapies and life-changing medications across diverse therapeutic areas
Remote work arrangement with minimal travel requirements (10-20%) offering optimal work-life balance
Access to cutting-edge clinical trial technologies and electronic systems including industry-leading platforms like Veeva Vault

Career Growth

Typical progression to Senior Clinical Trial Specialist within 2-3 years, with advancement to management roles possible within 4-5 years based on performance and additional certifications or advanced degrees.

Potential Next Roles

Senior Clinical Trial Specialist with expanded therapeutic area expertise and team leadership responsibilities Clinical Trial Manager overseeing multiple concurrent studies and managing junior staff Clinical Operations Manager with strategic oversight of departmental initiatives and client relationship management Regulatory Affairs Specialist focusing on submission strategy and regulatory agency interactions

Company Overview

Parexel

Parexel stands as one of the world's leading clinical research organizations with over 35 years of experience supporting pharmaceutical and biotechnology companies in drug development. The company has contributed to the approval of most of today's top-selling medications and maintains strategic partnerships with global pharmaceutical leaders, providing comprehensive clinical development services across all therapeutic areas.

Parexel holds a prominent position among the top 5 global CROs, competing directly with industry leaders like IQVIA, Syneos Health, and PPD. The company's FSP model differentiates it by providing dedicated, embedded teams that offer clients greater control and flexibility compared to traditional outsourcing arrangements.
Parexel maintains a strong presence in the UK clinical research market, serving as a key hub for European operations and supporting both local biotech companies and multinational pharmaceutical corporations conducting clinical trials across the EU regulatory framework.
The company emphasizes long-term career development and employee empowerment, with a collaborative culture that values scientific excellence and regulatory expertise. The FSP model fosters close client relationships and provides opportunities for deep therapeutic area specialization.
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