Clinical Operations Lead

Job Title: Clinical Operations Lead/Study Start-Up Lead (SSUL)

Pay Rate: £300–£500.00 Inside IR35

Location: Welwyn Garden City (AL7, AL8)

Length of Contract: 6 Months

Job Description

We are seeking an experienced Study Start-Up Lead (SSUL) to lead and coordinate clinical trial start-up activities across the UK. The role involves developing study start-up strategies, managing regulatory submissions, driving site activation, and ensuring compliance with clinical trial regulations and quality standards.

You will collaborate with global and local study teams, clinical research sites, regulatory authorities, and CRO partners to ensure efficient and timely study initiation.

Key Responsibilities

• Lead country-level study start-up strategies, including risk management, timeline planning and process improvement.
• Oversee UK clinical trial submissions, including HRA, Ethics Committee and MHRA submissions, amendments and regulatory queries.
• Drive site set-up and activation, ensuring documentation is complete and regulatory requirements are met.
• Manage Informed Consent Forms (ICFs), including preparation, submission and archiving.
• Oversee site documentation, patient-facing materials and compliance with UK clinical trial regulations, including medical device and IVDR requirements.
• Manage clinical site budgets, contract negotiations, confidentiality agreements, indemnity documentation and contract amendments.
• Oversee site payments, financial reconciliation, reporting and contract data management.
• Build effective relationships with clinical sites, regulatory bodies, internal stakeholders and external partners.
• Ensure alignment with global study strategies, timelines and operational standards.

Essential Skills and Experience

• Degree in Life Sciences or a related discipline; a postgraduate or Master's qualification is desirable.
• Proven experience in clinical trial start-up, regulatory submissions and site activation.
• Strong knowledge of UK clinical trial regulations and regulatory submission processes.
• Hands-on experience with IRAS, CPMS, iCT and ARSAC.
• Good understanding of ICH-GCP, EU Clinical Trials Regulation (EU CTR) and applicable UK regulatory requirements.
• Experience managing clinical site relationships and leading site set-up through to activation.
• Experience working with CROs, vendors and cross-functional teams.
• Familiarity with clinical trial systems such as Veeva Vault, CTIS and RIM.
• Excellent communication, organisational, analytical and problem-solving skills.
• Ability to manage complex activities and work effectively within global, cross-functional teams.
• Fluency in written and spoken English is essential.

Candidate Profile

We are looking for a proactive and detail-oriented clinical trial start-up professional with strong UK regulatory knowledge and the ability to drive site activation, manage stakeholder relationships and deliver study start-up activities efficiently and compliantly.

We use generative AI tools to support our candidate screening process. This helps us ensure a fair, consistent, and efficient experience for all applicants. Rest assured, all final decisions are made by our hiring team, and your application will be reviewed with care and attention.

Please be advised if you haven't heard from us within 48 hours then unfortunately your application has not been successful on this occasion, we may however keep your details on file for any suitable future vacancies and contact you accordingly.

Pontoon/Adecco is an employment consultancy. We put expertise, energy, and enthusiasm into improving everyone’s chance of being part of the workplace. We respect and appreciate people of all ethnicities, generations, religious beliefs, sexual orientations, gender identities, and more. We do this by showcasing their talents, skills, and unique experience in an inclusive environment that helps them thrive.