Study Start Up Lead

Talentmark are recruiting for a Study Start Up Leadto 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.
Salary:
339.27 pd to 376.97 pd PAYE or 450 pd to 500 pd via umbrella
Rates are dependent upon experience
Study Start Up Lead Role:

• 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.
Apply:
For more information, or to apply for this Study Start Up Lead please contact the Key Accounts Team on (phone number removed) or email (url removed). Please quote reference 71480.
It is essential that applicants hold entitlement to work in the UK
Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.

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