Job description
Senior Manager, Site Contracts & Budgets
The Role:
Here's What You'll Do:
Here's What You'll Bring to the Table:
Benefits:
About The Company:
- Contract Duration 6+ Months
- Pay rate up to $104/Hr
The Role:
- Reporting to the Senior Director, Clinical Site Management and Monitoring (CSMM) the Senior (Sr.) Manager, Site Contracts and Budgets are responsible for program and/or clinical trial-level management and oversight of site contract and budget negotiation and execution for Phase I-IV clinical trials at the client.
- The Senior Manager will collaborate closely with key CDO functional stakeholders, including CSMM, Clinical Trial Excellence and Support (CTES), and Clinical Operations in the development and ongoing oversight of site contracts and budgets execution during the clinical trial start-up (SSU) phase to support site activation as per target timelines.
Here's What You'll Do:
- Senior Manager, Site Contracts & Budgets will be responsible for direct oversight and management of site contracts and budgets for multiple assigned clinical trials within designated therapeutic areas.
- Provide consistent site contract/budget 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 the 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 the development of target FMV-based IG budget and negotiation parameters according to the therapeutic area (infectious disease, oncology, and/or therapeutics) in an outsourced CRO model.
- Act as the lead point of contact (POC) for CRO site contracts and 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.
- Senior Manager, Site Contracts & Budgets will be 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 the established clinical trial IG budget remains within target during the CTA negotiations process
- Serve as liaison between CRO and client 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 client/CRO clinical trial team meetings on an agenda-driven basis, i.e. when strategic decisions that impact site contracts are being discussed.
- Senior Manager, Site Contracts & Budgets will act as lead POC for required site contracts and/or budget amendments throughout the duration of assigned studies.
- Proactively identifies site contract-related risks and potential roadblocks.
- Escalates issues proactively to Senior Director, CSMM, and/or Clinical Operations teams to prevent delays in site activation timelines.
Here's What You'll Bring to the Table:
- Minimum 5 years of direct experience in global investigator site budget negotiations; 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.
- Strong experience in the use of various site contract and budget management systems, processes, and computer software (e.g., Grants Manager, Grant Plan)
- 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 the management of high volumes of investigator site financial data.
- Works on increasingly complex problems of diverse scopes 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.
- Need 3-5 YOE at biotech, pharma, or CRO
- Can be fully remote, looking for someone on EST or CT
- Need to have a legal background and be familiar with CTA (Clinical Trial Agreements)
- Need familiarity with confidential documents - CDA & non-disclosure agreements
- Need experience negotiating outside the US because this person will be working with CROs and developing strategies for contracting with sites in the EU, UK, Japan, Latin America, Asia, etc
Benefits:
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
About The Company:
- Our client operates as a developer of messenger RNA therapeutics. The company develops and discovers drugs that produce proteins or antibodies inside patient cells. Its pipeline includes various drug modalities such as prophylactic vaccines, therapeutic vaccines, intratumoral immuno-oncology, localized therapeutics, and liver intracellular. Through its mRNA therapeutics platform, they develop and produce human proteins, antibodies, and novel proteins, which help in preventing, treating, and curing diseases. It also develops therapeutics in the areas of infectious disease, rare liver disease, immuno-oncology, and cardiovascular disease.
- Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.
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