Study Start Up Lead

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 are recruiting for a Study Start Up Lead

to join a company in the pharmaceutical industry on a contract basis for 6 months.This role is hybrid with 2/3 days on site in Welwyn Garden City, and the rest home working.

Company:

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.

£339.27 pd to £376.97 pd PAYE or £450 pd to £500 pd via umbrella

Rates are dependent upon experience

• Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.
• Lead the development and oversight for UK clinical trial submissions (HRA, Ethics and MHRA), amendments and regulatory coordination, managing packages, responding to queries, ensuring document maintenance, and supporting amendments throughout the trial lifecycle.
• Strategically manage site documentation and compliance, overseeing document collection/validation, coordination of related processes, and local vendor management
• Strategically oversee the payment processes, escalations, and reporting, ensuring financial/regulatory contract compliance and participating in planning, management, and reconciliation of financial activities.
• Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance.

Your Background:

• Hold a relevant degree (MD, PhD, MA/MS, BA/BS) in life sciences or have equivalent working experience.
• Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration
• Strong understanding of ICH-GCP, EU CTR, and local regulatory environment.
• Experience managing vendor/CRO relationship.
• Experience management site relationships and leading site set up through to site activation
• Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.).

Company:

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.