Clinical Operations Lead

Clinical Operations Lead (Study Start-Up)

Position Details

• Job Title: Clinical Operations Lead (Study Start-Up Lead)
• Location: Welwyn Garden City, UK (Hybrid Working)
• Contract Duration: 6 months initially
• Pay Rate: £500.00 / day via Umbrella OR £375.00 / day PAYE

About the Role & Industry Context

Join a global, purpose-driven healthcare pioneer operating at the intersection of diagnostics and pharmaceuticals to bring innovative clinical trials to patients faster.

As a Clinical Operations Lead, your primary focus will be to drive and facilitate efficient study start-up processes across various therapeutic areas. You will enable innovative clinical trial delivery and ensure seamless trial execution for patients, investigators, and site staff.

Collaborating closely with internal country teams, global study teams, external stakeholders, and CRO partners, you will serve as the strategic driver for site activation and operational readiness.

Key Responsibilities

This role focuses on the efficient and compliant initiation of clinical trials by developing and implementing effective start-up strategies, overseeing country and site-level start-up operations, and driving process improvements while maintaining regulatory compliance.

• Start-Up Strategy & Execution: Lead cross-functional teams in creating and executing comprehensive study start-up strategies, incorporating proactive risk mitigation, tracking, knowledge management, and collaborative planning with CRO partners.
• Regulatory Submissions & Coordination: Lead the development, oversight, and submission management for UK clinical trials (HRA, Ethics, and MHRA), including managing submission packages, responding to authority queries, maintaining compliance, and managing study amendments throughout the trial lifecycle.
• Ethics & Health Authority Engagement: Engage proactively with government and institutional bodies (Ethics Boards, Health Authorities, etc.) to align on clinical trial policies, regulatory compliance, and best practices.
• Informed Consent Form (ICF) Management: Architect and strategically oversee the end-to-end ICF lifecycle, including preparation, submission, translation, and archiving to ensure strict regulatory and corporate alignment.
• Site Contracting & Budget Management:
• Provide strategic planning, drafting, negotiation, and implementation for clinical site contracts, NDAs/CDAs, indemnity/insurance documentation, and study budgets (utilising the interactive Costing Tool - iCT).
• Ensure financial and legal alignment across internal and external stakeholders, maintaining accurate contract data in systems to support planning and forecasting.
• Financial Management & Payments: Oversee site payment processes, financial escalations, reporting, reconciliation, and compliance against contractual agreements.
• Site Documentation & Local Vendors: Strategically manage site documentation collection/validation, local vendor management (excluding CROs), and oversee the translation and preparation of patient-facing materials.
• Regulatory Landscape: Maintain up-to-date expertise in UK-specific regulations governing medicinal products, medical devices, and In Vitro Diagnostic Regulations (IVDR).

Qualifications & Experience

• Education: Degree (BA/BS, MA/MS, PhD, or MD) in Life Sciences or a related field (Postgraduate/Master’s degree preferred).
• Clinical Trial Experience: Proven track record in clinical study start-up, site set-up leading to site activation, regulatory submissions, and cross-functional leadership.
• UK System Expertise: Strong hands-on experience with UK-specific clinical trial platforms and tools, including IRAS, CPMS, iCT, and ARSAC.
• Regulatory Knowledge: In-depth understanding of ICH-GCP, EU CTR, UK health authority environments, and medical device/IVDR requirements.
• Vendor & Site Management: Demonstrated expertise in managing site relationships and overseeing vendor/CRO partnerships.

Skills & Competencies

• Clinical Systems Proficiency: Familiarity with modern clinical trials platforms (e.g., Veeva Vault, CTIS, RIM, eTMF/CTMS systems).
• Leadership in Matrix Environments: Proven ability to lead through complexity, ambiguity, and change within global, matrixed organization structures.
• Communication & Collaboration: Exceptional written and verbal communication skills, with fluent English language proficiency.
• Analytical & Strategic Thinking: Strong organizational, problem-solving, and negotiation capabilities with fine attention to detail and compliance.