Budget and Contracts Manager

GSK

2d•$115,500 - $192,500•Remote

About The Position

The Budget and Contracts Manager plays a key role in GSK meeting its upper quartile performance objectives. This role is responsible for managing the clinical site agreement and budget process for US Pharma / Vaccines studies. This position reports into the ICBP Associate Director (Investigator Contracts Benchmarking and Payments). The Budget and Contracts Manager work with sites to obtain, confirm, and maintain required site level information that is necessary for the accuracy of clinical site agreements, and negotiate per patient budgets according to FMV parameters and following any exception processes.

Requirements

2+ years’ experience in clinical research and Bachelor’s degree, or 3+ years’ experience in clinical research and Associates degree (or equivalent) or 5+ years’ experience in clinical research without higher degree
Experience ensuring that clinical trial agreements are managed, and issues are appropriately escalated across the governance framework.
Experience with clinical study budget benchmarking and fair market value analysis, investigator site contracting, and investigator grant payments.
Experience with using Clinical Trial Management Systems (CTMS) and Trial Master Files (TMFs).
Experience participating in internal and external inspections and developing/implementing both preventive and corrective action plans.

Nice To Haves

Proficient in use of Microsoft products (Outlook, Excel, PowerPoint, etc.)
Familiar with AI tools/technology
Ability to create and maintain power queries and v-lookups is preferred
Experienced user of GrantPlan/GrantManager is preferred
Thrives in a matrix environment
Able to work independently, in a fast-paced environment
Has strategic thinking skills
Ability to analyze trend and metrics data (especially related to quality and performance) to communicate progress and drive continuous improvement.
Comprehensive knowledge of the clinical development process and protocol design.
Operationally focused with understanding of big picture strategy preferred.
Demonstrated ability to effectively communicate (written and verbal) and influence key stakeholders at all levels of the organization both internally and externally.
Able to manage multiple projects and priorities working across several trials and study teams.
Flexible and responsive to new ideas in a changing environment.
Recognizes potential obstacles or risks and works proactively to resolve them within set timelines. Escalates issues appropriately, articulating the actions required from members of the team.

Responsibilities

Comprehensive knowledge of clinical development process and importance of meeting major study milestones.
Site contracting language and study budget benchmarking/fair market value analysis experience.
Demonstrated ability to effectively communicate (written and verbal) and influence key stakeholders at all levels of the organization and externally.
Proven ability to identify legal language and budget related problems and works with internal and external team stakeholders to provide and implement solutions.
Ability to establish strong working relationships with internal and external stakeholders (e.g. legal, compliance, finance and sites).
Serves as main point of contact for internal and external stakeholders to meet site contracting/budgeting goals.
Establishes, maintains and updates training material for legal language and budget parameters for team and clinical site contract negotiators.
Serves as subject matter expert equipped to help resolve US legal language and site budgeting issues, and escalation point within the Company for both internal and CRO stakeholder support and guidance.
Liaise with GSK study team members to understand study specifics (enrollment goals, timelines, etc.) and provide study status reports including challenges and lessons learned.
Performs other work-related duties as assigned and following Standard Operating Procedures (SOPs) and Guidance documents.
Ensures investigator budget development and documentation complies with GSK SOPs, guidance and requirements.
Generates site-specific agreements using approved templates and any applicable study parameters.
Proposes site budgeting solutions to issues that may arise during development/negotiations of contract/budget cycle to enhance negotiation strategy and ensure deliverables are met.
Establishes strategies around investigator budget template development and/or budget negotiation parameters to reflect GSKs specifications, communications and required processes. Initiates and introduces creative ideas and solutions.
Works with study leads/SMEs to negotiate contract terms and conditions using fall back language and in collaboration with the US legal liaison, functional teams, and sites. Ensures agreements are clear, comprehensive, and complete.
Develops detailed investigator grant per patient budget estimates according to protocol specifications through currently available software package/resources/FMV tools.
Updates detailed investigator grant per patient budget estimates template according to protocol amendment specifications.