Study Start-Up Lead | Hybrid UK | Regulatory Activation

Ck Group; Welwyn Garden City; Hybrid; GBP 63,000 - 92,000; Full time

Job summary

Talentmark is recruiting for a Study Start Up Lead to join a biopharmaceutical company on a 6-month contract. The role is hybrid with 2/3 days on site in Welwyn Garden City and remaining days at home.

The candidate will lead UK study start-up strategy, oversee regulatory submissions, and manage site documentation and vendor relationships to ensure timely site activation and compliance.

Qualifications

• Degree in life sciences or equivalent experience.
• Experience in clinical trial start-up and regulatory submissions.
• Strong knowledge of ICH-GCP, EU CTR and local regulations.

Responsibilities

• Lead country-wide start-up strategy, driving efficiency and collaboration with external stakeholders.
• Oversee UK regulatory submissions (HRA, Ethics, MHRA) and amendments, document maintenance and queries.
• Manage site documentation, vendor/CRO relationships and local processes for site activation.
• Oversee payment processes, budgeting, and regulatory contract compliance.
• Ensure timely start-up operations and regulatory compliance of sites.

Skills

Clinical trial start-up

Regulatory submissions

Cross-functional collaboration

Vendor management

Site activation

Education

MD/PhD/MA/MS/BA/BS in life sciences

Tools

Veeva Vault

CTIS

RIM

Job description

Talentmark is recruiting for a Study Start Up Lead to join a biopharmaceutical company on a 6-month contract. The role is hybrid with 2/3 days on site in Welwyn Garden City and remaining days at home.

The candidate will lead UK study start-up strategy, oversee regulatory submissions, and manage site documentation and vendor relationships to ensure timely site activation and compliance.