Clinical Operations Specialist

Clinical Operations Lead (Study Start-Up)

Location: UK (Hybrid – Welwyn Garden City / field-based with flexibility)

Contract Type: Contract

Work Model: Hybrid (site visits required)

Role Overview

We are seeking an experienced Clinical Operations Lead (Study Start-Up) to drive and deliver efficient, compliant clinical trial start-up activities across the UK.

In this role, you will lead country-level start-up strategy and execution, ensuring timely site activation, regulatory compliance, and seamless collaboration across global study teams, CROs, and external stakeholders. You will play a critical role in enabling innovative clinical trial delivery and accelerating patient access to studies.

Key Responsibilities

Study Start-Up Strategy & Execution

• Lead the development and execution of country-level study start-up strategies
• Drive efficiency, innovation, and risk mitigation across start-up activities
• Ensure alignment with global timelines and operational plans
• Collaborate with cross-functional teams and CRO partners

Regulatory Submissions & Coordination

• Lead UK regulatory submissions (HRA, MHRA, Ethics)
• Manage submission packages, responses to queries, and amendments
• Ensure ongoing compliance with ICH-GCP, EU CTR, and local regulations
• Maintain accurate regulatory documentation throughout the trial lifecycle

Site Activation & Management

• Oversee end-to-end site start-up and activation timelines
• Manage site documentation collection, validation, and compliance
• Support preparation and translation of patient-facing materials
• Maintain strong relationships with clinical sites and investigators

Informed Consent Form (ICF) Management

• Oversee ICF development, submission, and archiving
• Ensure alignment with regulatory and corporate standards

Contracts, Budgets & Payments

• Lead site budgeting and contract negotiations
• Oversee contract execution (CDAs, indemnity, insurance, amendments)
• Manage financial tracking, payments, and reconciliation processes
• Ensure compliance with financial and legal frameworks

Stakeholder Engagement

• Engage with regulatory authorities, ethics committees, and institutional bodies
• Collaborate with internal global teams and external vendors
• Drive alignment across multiple stakeholders in a matrix environment

Required Qualifications

• Degree in Life Sciences (BA/BSc minimum)
• Postgraduate qualification (MSc, PhD, etc.) – desirable
• Strong background in clinical research with focus on study start-up

Essential Experience

• Proven experience in UK clinical trial start-up
• Hands-on regulatory submission experience (HRA, MHRA, Ethics)
• Strong knowledge of ICH-GCP and EU Clinical Trial Regulation (CTR)
• Experience managing site activation from initiation to activation
• Proficiency in systems such as IRAS, CPMS, iCT, Veeva Vault, CTIS, RIM
• Experience working cross-functionally within global teams

Preferred Experience

• Experience within a pharmaceutical or biotech sponsor environment
• Vendor/CRO management experience
• Exposure to clinical trial budgeting, contracts, and payments
• Experience across multiple therapeutic areas

Skills & Competencies

• Strong leadership and stakeholder management skills
• Excellent communication and interpersonal abilities
• High attention to detail with strong organizational skills
• Analytical mindset with problem-solving capabilities
• Ability to operate effectively in complex, matrixed environments
• Adaptable and collaborative approach

Candidate Profile

We are looking for:

• Professionals who have led UK study start-up strategy and execution
• Strong regulatory experts with hands-on submission experience
• Candidates who own site activation timelines end-to-end
• Confident communicators with strong stakeholder engagement skills

We are not looking for:

• CRA profiles with limited start-up exposure
• Candidates without UK regulatory experience
• Pure project managers lacking regulatory depth
• Junior candidates without ownership of start-up activities