Sr. Manager, Investigator Site Budgets

job summary :

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responsibilities :

Reporting to the Director, Clinical Development Operations (CDO) Business Analytics & Operations Management (BAOM), the Senior (Sr.

Manager, Site Budgets will focus on the generation and review of investigator site using GrantManager. 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 company internal data, third-party vendor data, as well as industry data.

The Sr. Manager will collaborate closely with key Clinical Operations functional stakeholders and Contract Research Organizations (CRO) in the development and ongoing oversight of site budget / contract 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.
• 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 company 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 company / 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.

qualifications :

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.
• 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.

skills : MS-EXCEL

MS-EXCEL