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.
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Study Start Up Lead in Welwyn Garden City employer: CK Group
Join a leading global pharmaceutical company in Hatfield, Hertfordshire, where your role as a Maintenance Coordinator will be pivotal in driving operational excellence and regulatory compliance. With a strong emphasis on employee development, a collaborative work culture, and a commitment to continuous improvement, this organisation offers a rewarding environment for professionals looking to make a meaningful impact in the industry. Enjoy competitive benefits and the opportunity to work alongside cross-functional teams dedicated to optimising asset performance and ensuring the highest standards of quality.
