Budget and Contracts Manager

Role Summary

Budget and Contracts Manager, located in Upper Providence, Pennsylvania, USA, is responsible for preparing, negotiating and facilitating execution of US Clinical Site contracts and budgets for Pharma and Vaccines studies, including the US budget and site budget build. The role involves objective review of contracting parties’ requested budgets and language changes and ensures accuracy of clinical trial agreements. This position reports to the ICBP Associate Director and collaborates with ICBP staff, Global Site Budgets & Contracts, R&D Legal, and study teams to develop and confirm CTAs and apply appropriate fallback language.

Responsibilities

• Develops and builds the US budget, site budget and language templates for Pharma and Vaccine studies.
• Provides expert guidance to develop detailed specifications and negotiate content of clinical trial agreements that are robust, timely, and add significant value while minimizing legal, operational and financial risk during the contract life cycle.
• Participates in creating and delivering solutions to simplify work practices, increase productivity and reduce waste.
• Serve as legal language subject matter expert between R&D Legal Operations, GSBC and other internal subject matter experts and external parties on US CTA issues.
• In the event the contracting party does not proceed forward with the initial offer, perform due diligence checks including fair market value analysis and review of site justifications.
• Determine whether requested changes warrant a budget and/or language escalation and seek appropriate approvals.
• Escalate delays, impact to timelines, or risks that could prevent fully executed CTAs within specified timelines.
• Proficient in Excel and other clinical trial management tools.
• Demonstrate effective oral and written communication, incorporating feedback into deliverables to generate quality output.
• Continuously develop knowledge of GCP, internal guidelines, SOPs, ways of working, and new technologies and capabilities.
• Experience with clinical study protocols and study timelines/milestones (e.g., SIV).
• Lead and support diverse projects and initiatives as needed.
• Build and maintain relationships with internal and external stakeholders (e.g., Site Engagement, Study Startup, GSBC, study sites) to add value to GSK-sponsored trials; interface with central study teams and business line leaders.
• Support a culture of trust, respect, transparency and accountability.
• As US subject matter expert for site contracting and budgets, lead and support internal and external inspections and aid in preventive/corrective action planning.
• Provide support to study teams and sites to resolve payment issues, including coordination with the global payment SME and payments vendor.
• Timely and accurate updating of departmental databases and trackers.
• Train and support additional staff as required.
• Participate in diverse project teams, remotely.

Qualifications

• Required: 3+ years’ experience in clinical research and Bachelor’s degree, or 5+ years’ experience in clinical research and Associate’s degree.
• Required: Experience ensuring that clinical trial agreements are managed and issues escalated across the governance framework.
• Required: Experience with clinical study budget benchmarking and fair market value analysis, investigator site contracting, and investigator grant payments.
• Required: Experience with using Clinical Trial Management Systems (CTMS) and Trial Master Files (TMFs).
• Required: Experience analyzing trend and metrics data to communicate progress and drive continuous improvement.
• Required: Experience participating in internal and external inspections and implementing preventive and corrective actions.
• Preferred: Oncology experience strongly preferred.
• Preferred: Knowledge of the clinical development process and protocol design.
• Preferred: Operationally focused with understanding of big picture strategy.
• Preferred: Demonstrated ability to effectively communicate (written and verbal) and influence stakeholders at all levels.
• Preferred: Able to manage multiple projects across several trials and study teams.
• Preferred: Flexible and responsive to new ideas in a changing environment.
• Preferred: Proficient in Microsoft Outlook, Excel, PowerPoint; power queries and V-lookups are a plus.
• Preferred: GrantPlan experience is a plus.
• Preferred: Thrives in a matrix environment and can work independently in a fast-paced environment.
• Preferred: Has strategic thinking skills.

Skills

• Proficient in Excel and other clinical trial management tools.
• Strong oral and written communication skills; ability to influence stakeholders.
• Analytical skills to analyze trend and metrics data related to quality and performance.
• Relationship-building with internal and external stakeholders and ability to work in a matrix organization.

Additional Requirements

• Available and willing to travel as job requires.