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 Beacon Hill is an equal opportunity employer and individuals with disabilities and/or protected veterans are encouraged to apply. California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/ Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. Company Profile: Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement. Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs. Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com . Benefits Information: Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required by applicable agency regulations to those that meet eligibility. Upon successfully being hired, details will be provided related to our benefit offerings. We look forward to working with you! Beacon Hill. Employing the Future™
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