Budget and Contracts Manager

Role Summary

The Contract Manager plays a key role in GSK Clinical Operations meeting its upper quartile performance objectives. This position 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 builds. It also involves objective review of sites' budgets and requested language changes and ensuring accurate clinical trial agreements with proper fallback language where needed.

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 the content of clinical trial agreements that are robust, timely, and add 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.
• Serves as a legal language subject matter expert between R&D Legal Operations, GSBC, and other internal/external parties on US CTA issues.
• Performs due diligence checks (including Fair Market Value and review of site justifications) if the contracting party does not proceed with the initial offer.
• Determines whether contracting party requested changes warrant a budget and/or language escalation and seeks appropriate approvals.
• Escalates delays, timeline impacts, or risks that could prevent a fully executed CTA within specified timelines.
• Proficient in Excel and other clinical trial management tools.
• Demonstrates effective oral and written communication and incorporates feedback into deliverables to generate quality outputs.
• Continuously develops knowledge of GCP, internal guidelines, SOPs, Work Instructions, Ways of Working, and new technologies and capabilities.
• Has experience with clinical study protocols and study timelines/milestones (e.g., SIV).
• Leads and supports diverse projects and initiatives as needed.
• Builds and maintains relationships with internal and external stakeholders (such as Site Engagement, Study Startup, GSBC, and study sites) to add value to GSK-sponsored clinical trials; regularly interfaces with central study teams and business line leaders.
• Drives a culture of trust, respect, transparency and accountability.
• As US subject matter expert for site contracting and budgets, can lead and support internal and external inspections and aid in the development and implementation of preventive/corrective action plans.
• Provides support to study teams and sites to resolve payment issues, including engagement with the global payment SME and payments vendor.
• Ensures timely and accurate updating of all departmental databases and trackers.
• Trains and supports additional staff as required.
• Participates in diverse project teams, remotely.
• Available and willing to travel as the job requires.

Qualifications

• Required: 3+ years’ experience in clinical research with a Bachelor’s degree, or 5+ years’ experience in clinical research with an Associate degree.
• Required: Experience ensuring that CTAs 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 Clinical Trial Management Systems (CTMS) and Trial Master Files (TMFs).
• Required: Experience analyzing trend and metrics data related to quality and performance to communicate progress and drive continuous improvement.
• Required: Experience participating in internal and external inspections and developing/implementing preventive and corrective action.
• 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 of the organization.
• Preferred: Ability to manage multiple projects and priorities across several trials and study teams.
• Preferred: Flexible and responsive to new ideas in a changing environment.
• Preferred: Recognizes potential obstacles or risks and works proactively to resolve them within set timelines; escalates issues appropriately, articulating the actions required from team members.
• Preferred: Proficient in Microsoft Outlook, Excel, PowerPoint; ability to create and maintain Power queries and V-lookups is preferred.
• Preferred: Experienced user of GrantPlan is preferred.
• Preferred: Thrives in a matrix environment.
• Preferred: Able to work independently in a fast-paced environment.
• Preferred: Has strategic thinking skills.

Education

• Bachelor’s degree in clinical research or a related field, or an Associate degree with significant clinical research experience (or equivalent). If using an Associate degree, substantial clinical research experience is expected.

Additional Requirements

• Travel as required.