Sr. Manager, Site Budgets & Contracts

Moderna • Toronto, ON

6d • Onsite

About The Position

Reporting to the Director, Global Clinical Operations (GCO) Business Analytics & Operations Management (BAOM), the Senior (Sr.) Manager, Site Budgets & Contracts will focus on the generation and review of investigator site budgets related to investigator grants (IGs) using Grants Manager. This 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. The Sr. Manager will collaborate closely with key GCO 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.

Requirements

• Minimum 5 years’ direct experience in global investigator site budget creation and negotiations
• Strong experience in the use of GrantManager/GrantPlan
• Preferable experience in CTA template language negotiations and/or support in collaboration with Legal.
• Effective communication and collaboration with key internal and external stakeholders, including CDO, CRO and investigator site personnel.
• Strength in financial analysis and financial justification.
• Familiarity in working within an outsourced model; experience in direct CRO oversight of CTA/budget negotiations.
• 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.
• Increasingly exercising independent judgment in developing methods and techniques to obtain solutions (and process improvements).
• Increasing independence in determining specific tasks to accomplish in order to meet certain goals and objectives.
• Increasing self-reliance in performing tasks.
• Works in a team environment.

Responsibilities

• 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.
• Lead and/or contribute to development of target FMV-based IG budget and negotiation parameters according to therapeutic area (infectious disease, oncology and/or therapeutics) in an outsourced CRO model.
• Act as lead point of contact (POC) for CRO site budgets-related activities for assigned studies; oversee the development and approval of global investigator site budgets and associated negotiation parameters.
• Ensure cross-program/cross-clinical trial consistency in country-level site budget targets and parameters.
• Responsible for direct management and tracking of CRO investigator site CTA/budget negotiations in alignment with FMV and GCP-driven principles.
• Collaborate with assigned CRO and Clinical Operations in ensuring that established clinical trial IG budget remains within target during CTA negotiations process.
• Serve as liaison between CRO and Moderna Legal/Clinical Contracts and Outsourcing teams in the review and finalization of country-level CTAs/CSA templates.
• Monitor KPIs, including cycle times and SIV/site activation targets, to ensure adherence to baseline clinical trial timelines for CTA negotiation and site activation.
• Attend Clinical Trial Team (CTT) and/or joint Moderna/CRO clinical trial team meetings on an agenda-driven basis, i.e. when strategic decisions that impact site contracts are being discussed.
• 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.
• Escalates issues proactively to Director, BAOM or AD, Site Contracts and Budgets and/or Clinical Operations teams to prevent delays in site activation timelines.
• Assist with the development of departmental processes, SOPs, budget/contract standards and other special projects as requested.

Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being with access to fitness, mindfulness, and mental health support
• Family building benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed