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Contract Site Manager

2 months ago

United Kingdom Planet Pharma Full time

This contract position requires a candidate with extensive experience using Grants Manager and/or GrantPlan and the ability to produce accurate Phase 1 – IV IG budgets efficiently. The ideal candidate will also provide valuable input into scenario planning and its impact on the study budget. The budgets will be validated against Moderna internal data, third-party vendor data, as well as industry data. Manager will collaborate closely with key CDO functional stakeholders, Contract Research Organizations (CRO) and Clinical Operations in the development and ongoing oversight of site budget execution during the clinical trial start up (SSU) phase to support site activation as per target timelines.
Responsible for creation & direct oversight/management of site budgets for multiple assigned clinical trials within designated therapeutic area.
Provide consistent site contract/budgets oversight and support to assigned Clinical Operations clinical trial teams, offering up-front and ongoing strategic planning specific to the program and needs of individual studies.
Leverage use of internal and CRO provided Investigator Grants (IG) reference data and available Fair Market Value (FMV) benchmarking tools to establish clinical trial-specific IG budget estimates for trial budget forecasting needs.
Responsible for direct management and tracking of CRO investigator site CTA/budget negotiations in alignment with FMV and GCP-driven principles.
Serve as liaison between CRO and Moderna Legal/Clinical Contracts and Outsourcing teams in the review and finalization of country-level CTAs/CSA templates.
Act as lead POC for required site contract and/or budget amendments throughout the duration of assigned studies.
Proactively identifies site contract-related risks and potential roadblocks.
preferable experience in CTA template language negotiations and/or support in collaboration with Legal.
Proficient in MS Office Products with advanced knowledge of Excel; ability to work with and be proficient in stand-alone system applications.
High level of attention to detail in management of high volumes of investigator site financial data.
Works on increasingly complex and problems of diverse scope requiring critical analysis and comprehensive evaluation of critical factors.