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Sr. Manager, Investigator Site Budgets & Contracts

Moderna

Senior
Sign in to applyVerified 1h ago
Level
Senior
Posted
19h ago

Skills

GCPGenAI

About this role

If you’re interested in this role, please apply in English and include an English version of your Resume/CV.

The Role

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its international business services hub in Warsaw, supporting our growing global operations. We welcome professionals ready to help advance our mission and shape the future of mRNA medicines. As a Senior Manager, Investigator Site Budgets & Contracts, you will play a critical role in enabling the successful delivery of Moderna's global clinical trials. Working as an individual contributor within Global Clinical Operations, you will lead the development and oversight of investigator site budgets and contract strategy, partnering with Clinical Operations, Contract Research Organizations (CROs), Legal and other key stakeholders to accelerate study start-up while maintaining the highest standards of quality, compliance and financial stewardship. This is an opportunity to combine deep expertise in investigator grants, Fair Market Value (FMV) methodologies and clinical trial contracting with strategic thinking and operational excellence. You'll help shape global budget strategies, optimise clinical trial execution and leverage emerging digital technologies, including Generative AI-enabled tools, to enhance forecasting, operational insights and process efficiency across Moderna's clinical development organisation. Here's What You'll Do: Lead the creation, management and oversight of investigator site budgets for multiple global clinical trials across assigned therapeutic areas. Generate and review accurate Phase I-IV investigator grant (IG) budgets using Grants Manager and/or GrantPlan. Support scenario planning by evaluating budget assumptions and assessing their impact on overall study budgets and financial forecasts. Validate investigator grant budgets using Moderna internal data, third-party vendor data, CRO reference data and industry benchmarking information. Provide strategic site budget and contract guidance to assigned Clinical Operations teams throughout study start-up and clinical trial execution. Leverage internal and CRO investigator grant reference data together with Fair Market Value (FMV) benchmarking tools to establish study-specific budget estimates. Lead and contribute to the development of FMV-based investigator grant budgets and negotiation parameters across infectious disease, oncology and therapeutic programmes operating within an outsourced CRO model. Serve as the primary point of contact for CRO site budget activities across assigned studies. Oversee the development, approval and consistency of global investigator site budgets and negotiation parameters across countries, studies and programmes. Directly manage and track CRO investigator site Clinical Trial Agreement (CTA) and budget negotiations, ensuring alignment with FMV principles and Good Clinical Practice (GCP) expectations. Collaborate with CROs and Clinical Operations teams to ensure approved investigator grant budgets remain within target throughout the CTA negotiation process. Act as the liaison between CROs and Moderna Legal, Clinical Contracts and Outsourcing teams during the review and finalisation of country-level Clinical Trial Agreement (CTA) and Clinical Study Agreement (CSA) templates. Monitor key performance indicators, including negotiation cycle times, Site Initiation Visit (SIV) metrics and site activation targets to ensure delivery against clinical trial timelines. Participate in Clinical Trial Team (CTT) meetings and joint Moderna/CRO governance meetings when strategic site contract decisions are required. Lead site contract and budget amendment activities throughout the lifecycle of assigned clinical studies. Proactively identify site contract risks, negotiation challenges and operational roadblocks while

Sr. Manager, Investigator Site Budgets & Contracts at Moderna | Yoinka