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The contractor for Site Budgets and Contracts is responsible for executing all aspects of the clinical site contracting, negotiation and execution of required budgets and agreements in support of clinical studies. The role will coordinate activities across CROs, study sites, study teams, and internal stakeholders (Legal, Finance, Compliance) to effectively deliver negotiated site agreements that balance risk and budget, while understanding and achieving key deadlines. This role reports into the Head, Clinical Development Operational Excellence and Operations and may occasionally be asked to work on other vendor-related contracts/budgets or investigator-sponsored trials as identified
Key Responsibilities
Site Budgets
- In close partnership with the CROs and leveraging their regional and local expertise, and working with internal colleagues, develop standard site budget templates using industry grant benchmarking software and leveraging budget precedent whenever possible
- Oversee and partner with CRO on site negotiations while ensuring fair market value (FMV). Proactively identify risks with clinical site budgets, develop risk mitigation plans, and escalate appropriately during the negotiation process including direct negotiation with sites as needed.
- Maintain oversight of CROs to ensure compliant and timely execution of budget amendments
- Meet tight study deadlines ensuring sites/PI contracts are able to meet Ready to Enroll (RTE) Targets
- Ensure consistent approach to site budgets across studies/programs.
- Resolve site budget inquiries from stakeholders, i.e., Study Teams, CRO team members and Site/PIs with a sense of urgency and understanding importance of deadlines, Clinical Trial Agreements, Amendments and Ancillary Agreements
- Work with the CRO and Legal to generate approved study agreement templates. Leverage existing master and historical site agreements and CRO expertise wherever possible.
- Act as the first level of support for contract language escalations. Leverage company-approved fallback language and positions to expedite execution of an approved agreement. Escalate to and work with Legal to identify alternatives for any contract language that falls outside of approved language
- Coordinate and track the contracting activities across studies during startup phase. Act as single point of contact for the CROs and conduit between Legal, the CROs and sites.
- Maintain oversight of CROs to ensure compliant and timely execution of site contracts and contract amendments.
- Develop and manage the overall CTA timeline, track progress and provide regular updates to key stakeholders. Provide a portfolio level view across all studies.
General
- Able to work in a fast-paced, highly visible role
- Provide high level of customer service to PIs, Sites, CROs and internal colleagues
- Excellent oral, written and presentation communication skills to ensure stakeholders are informed of budget and contract status in a timely fashion
- Excellent time management skills, ability to prioritize with deep understanding of study timelines and milestones to achieve corporate goals.
- Identify process improvements and innovative approaches to the site contract/budget process.
- Support negotiation of other vendor agreements or investigator-sponsored trials if requested
Qualifications:
- Bachelor’s degree required
- 7+ years’ experience in the biotechnology/pharmaceutical industry with at least 3 years of direct experience negotiating site budgets and contracts across late phase clinical studies in both the US and internationally
- Deep experience in negotiations, managing CROs and creative and compliant conflict resolution and problem solving
- Thorough understanding of Clinical Operations, GCP, relevant ICH standards, and FDA/EMA guidelines.
- Deep understanding of site budget structure, including key cost drivers and common negotiation sticking points
- Knowledge of and experience working with site contracts and common legal terms and conditions
- Experience using outputs from trial cost benchmarking software
- Ability to prioritize needs and handle a high volume of tasks within tight clinical timelines
- Ability to build networks and collaborate with CRO and internal stakeholders
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