Study Start-Up Lead

Talentmark; Welwyn Garden City; On-site; GBP 70,000 - 110,000; Full time

Job summary

Talentmark in the United Kingdom is seeking a senior professional to lead the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders across trials.

You will oversee UK clinical trial submissions (HRA, Ethics, MHRA), amendments, and regulatory coordination, while managing site documentation, vendor relations, and the start-up lifecycle to ensure timely activation.

Qualifications

• Hold a relevant degree (MD, PhD, MA/MS, BA/BS) in life sciences or 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 relationships.

Responsibilities

• Lead the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.
• Oversee 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.

Skills

Clinical trial start-up

Regulatory submissions

Cross-functional collaboration

Education

MD/PhD/MA-MS/BA/BS in life sciences or equivalent

Tools

Veeva Vault

CTIS

RIM

Job description

• 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.).