Clinical Operations Lead

Adecco Portugal; Welwyn Hatfield; Hybrid; GBP 63,000 - 92,000; Part time

Benefits offered by this job

Disability confident employer

Inclusive recruitment

Job summary

Adecco Portugal is seeking a Clinical Operations Lead to steer study start-up activities, support regulatory submissions, and drive site activation across the UK. The role is hybrid (2-3 days in office) in Welwyn Garden City on a 6-month contract.

The ideal candidate holds a Life Sciences degree with proven clinical operations experience, UK submission expertise (IRAS, MHRA, HRA, Ethics), and strong ICH-GCP knowledge. Collaboration with global teams and vendors is essential.

Qualifications

• Degree in Life Sciences or related discipline.
• Experience in clinical operations or study start-up in pharma/CRO.
• Experience managing UK submissions through IRAS, MHRA, HRA.
• Knowledge of ICH-GCP, EU CTR, UK regulations.
• Experience from start-up to site activation.
• Exposure to site contracts and budgets.

Responsibilities

• Lead country-level study start-up activities.
• Oversee trial submissions and approvals with MHRA, HRA, Ethics Committees.
• Drive site activation aligned with project timelines.
• Collaborate with global study teams, CROs, investigators and site personnel.
• Manage amendments through the clinical trial life cycle.
• Support site contracts and budgets.
• Maintain study documentation per ICH-GCP and EU CTR.
• Identify operational risks and mitigation strategies.

Skills

Regulatory submissions

Site activation

ICH-GCP

UK regulations

Stakeholder management

Clinical operations

Education

Degree in Life Sciences

Tools

CTIS

Veeva Vault

CPMS

Job description

Clinical Operations Lead

Location: Welwyn Garden City

Contract Length: 6 months

Hybrid: 2-3 days in office

Daily Rate: £339.27 - £500.00 InsideIR35

Our client, a leading organisation within the pharmaceutical industry, is seeking a highly skilled Clinical Operations Lead to join their clinical research team. This is an exciting opportunity for an experienced professional to lead study start-up activities, support regulatory submissions, and drive the successful activation of clinical trial sites across the UK.

Key Responsibilities:

• Lead country-level study start-up activities to support the successful delivery of clinical trials across multiple therapeutic areas.
• Oversee clinical trial submissions and approvals, including interactions with MHRA, HRA, Ethics Committees and other regulatory bodies.
• Drive site activation activities, ensuring studies are initiated in line with project timelines and regulatory requirements.
• Collaborate with global study teams, CROs, investigators and site personnel to support efficient study start-up and delivery.
• Manage study amendments throughout the clinical trial life cycle, ensuring compliance with applicable regulations and internal procedures.
• Support site contract and budget activities, including negotiation, execution and ongoing management.
• Maintain accurate study documentation and ensure adherence to ICH-GCP, EU CTR and other relevant regulatory requirements.
• Proactively identify operational risks and implement mitigation strategies to support study milestones and delivery targets.

Qualifications and Experience:

• Degree in Life Sciences or a related discipline, or equivalent industry experience.
• Proven experience within clinical research, clinical operations or study start-up in a Pharmaceutical, Biotechnology or CRO environment.
• Experience managing UK clinical trial submissions through IRAS, MHRA, HRA and Ethics Committee processes.
• Strong understanding of ICH-GCP, EU CTR and UK clinical trial regulations.
• Experience supporting studies from start-up through to site activation.
• Exposure to site contracts, budgets and vendor/CRO management.
• Experience using clinical systems such as CTIS, Veeva Vault, CPMS or similar platforms.
• Strong stakeholder management, communication and organisational skills.

Adecco is a disability-confident employer. It is important to us that we run an inclusive and accessible recruitment process to support candidates of all backgrounds and all abilities to apply. Adecco is committed to building a supportive environment for you to explore the next steps in your career. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.

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.