UK Clinical Start-Up Lead: Submissions & Site Activation

Adecco (Portugal); Welwyn Garden City; Sur place; GBP 60 000 - 90 000; Plein temps

Résumé du poste

Adecco is seeking a Clinical Operations Lead/Study Start-Up Lead (SSUL) for UK responsibilities in Welwyn Garden City. The role focuses on leading start-up strategies, regulatory submissions, and timely site activation for clinical trials.

You will collaborate with global teams, sites, and CRO partners, ensuring compliance with UK regulations and quality standards while managing budgets, ICFs, and contract documentation.

Qualifications

• Degree in Life Sciences or related field; postgraduate preferred.
• Proven experience in study start-up, regulatory submissions and site activation.
• Solid knowledge of UK trial regulations and submission processes.
• Experience with IRAS, CPMS, iCT and ARSAC systems.
• Ich-GCP, EU CTR and UK regulatory requirements understanding.
• Experience managing site relationships and cross-functional teams.
• Familiar with CROs, vendors and clinical trial systems.

Responsabilités

• Lead country-level start-up strategies, risk management and timelines.
• Oversee UK submissions (HRA, Ethics Committee, MHRA) and amendments.
• Drive site setup and activation with complete regulatory documentation.
• Manage ICFs including preparation, submission and archiving.
• Oversee site documentation and patient-facing materials per UK regs.
• Manage site budgets, contracts, confidentiality and amendments.
• Oversee site payments, reconciliation and data management.
• Build relationships with sites, regulatory bodies and partners.
• Align with global study timelines and operational standards.

Connaissances

Clinical trial start-up

Regulatory submissions

UK regulatory knowledge

Stakeholder management

Cross-functional teamwork

English communication

Formation

Life Sciences degree

Outils

IRAS

CPMS

iCT

ARSAC

Veeva Vault

CTIS

RIM

Description du poste

Adecco is seeking a Clinical Operations Lead/Study Start-Up Lead (SSUL) for UK responsibilities in Welwyn Garden City. The role focuses on leading start-up strategies, regulatory submissions, and timely site activation for clinical trials.

You will collaborate with global teams, sites, and CRO partners, ensuring compliance with UK regulations and quality standards while managing budgets, ICFs, and contract documentation.