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Clinical Site Contracts

3 months ago

HybridRemote, UK, United Kingdom myGwork Full time

This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community.

Join the Parexel FSP Team as a Clinical Budget & Contracts Lead

Are you ready to make a real impact on the success of our clinical trials? We're seeking a talented individual to play a crucial role in ensuring performance and compliance with assigned protocols. As a Finance Clinical Operations Manager, you'll navigate the complexities of ICH/GCP regulations, oversee budget and finance aspects, and drive excellence to deliver results.

Dedicated to one sponsor, a global pharmaceutical company that leads the way in discovering and developing innovative health solutions that help prevent and treat diseases in animals and people.

Our sponsor has a long history of excellence in research, delivering medicines, vaccines, and other health solutions for some of the most difficult diseases in the world.

Responsibilities:

  • Budget Ownership: Manage country and site budgets, including development, negotiation, and completion of Clinical Trial Research Agreements (CTRA).

  • Financial Oversight: Track clinical research-related payments, reconcile payments at study closeout, and maintain financial systems. Collaborate with Sr. COM and other roles for financial forecasting.

  • Protocol Management: Ensure country deliverables, timelines, and results align with commitments. Maintain quality and compliance for assigned protocols.

  • Local SOP Development: Contribute to the development of local Standard Operating Procedures (SOPs) and oversee Clinical Trial Coordinators (CTCs) as applicable.

  • Collaboration: Coordinate with CRM, CTC, CRA, and other relevant teams (Finance and Legal) to obtain country deliverables for submissions, budgets, CTRAs, and local milestones. Align country timelines with headquarters for assigned protocols.

  • Vendor Support: Provide oversight and support to local vendors as needed.

  • Financial Compliance: Oversee local financial compliance, ensuring adherence to budget targets and payment timelines.

  • Influence and Partnership: Work internally with GCTO country operations, finance, legal, and regional teams, as well as externally with vendors and sites. Influence investigators and external partners.

Experience required:

  • 5 years in clinical research or combined experience in Clinical Research and Finance/Business.

  • Experience in the development, negotiation, and completion of clinical trial agreements.

  • Experience in oversight and tracking of clinical research‐related payments

  • Experience in payment reconciliation at study close‐out.

  • Experience in financial forecasting.

  • Education: Bachelor's degree in business finance/administration, life science, or equivalent healthcare-related experience.

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