Budget and Contracts Manager

GSK

About The Position

The Contract Manager plays a key role in GSK Clinical Operations meeting its upper quartile performance objectives. This role is responsible for preparing, negotiating and facilitating execution of the US Clinical Site contracts and budgets required for US Pharma / Vaccines studies which includes the US budget and site budget build. In addition, the Contract Manager is responsible for objective review of the contracting parties (sites) requested budget and language changes. This position reports to the ICBP (Investigator Contracts Benchmarking and Payments) Associate Director. The Contract Manager works closely with ICBP staff, Global Site Budgets & Contracts (GSBC), R&D Legal, and study teams not only to negotiate but to develop, obtain, review and confirm the accuracy of clinical trial agreements (CTAs) and ensure proper fall-back language has been applied as necessary. Key Responsibilities: Develops and builds the US budget, site budget & language templates for Pharma & Vaccine studies. Provides expert guidance to develop detailed specifications and negotiate content of clinical trial agreements that are robust, timely, and add significant opportunity for value generation to the business while minimizing legal, operational and financial risk to GSK during the contract life cycle. Participates in creating and delivering solutions for simplifying work practices to increase productivity and reduce waste. Serve as legal language subject matter expert between GSK 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 the Contractor Manager is responsible for performing due diligence checks which includes but is not limited to Fair Market Value and review of site justifications. Determine if the contracting party’s requested changes warrant a budget and/or language escalation and to seek the appropriate approvals. Escalate delays, impact to timelines, or risks that limit the ability to deliver a fully executed CTA within the timelines specified. The Contract Manager should be proficient in excel and other clinical trial management tools. Demonstrate effectiveness in both oral and written communication. Effectively express ideas and incorporate feedback into deliverables to generate quality output. Continuously development of knowledge of GCP, internal company guidelines, SOPs, Work Instructions, Ways of Working, new technologies and capabilities. The Contract Manager should have experience with clinical study protocols and study timelines and milestones (i.e. SIV). Leads and supports diverse projects and initiatives as needed. Effectively 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 interface with GSK central study teams and business line leaders. Drives a culture of trust, respect, transparency and accountability As the US subject matter expert (SME) for site contracting and budgets, the Contract Manager should be able to lead and support internal and external inspections and aid in the development and implementation of preventative/corrective action plans. Provide appropriate support to study teams and sites as needed to resolve payment issues which may include engaging with our global payment SME and our payments vendor. Timely and accurate updating of all departmental databases and trackers. Train and support additional staff, as required. Ability to participate in diverse project teams, remotely. Available and willing to travel as job requires.

Requirements

3+ years’ experience in clinical research and Bachelor’s degree, or 5+ years’ experience in clinical research and Associates 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 analyzing trend and metrics data (especially related to quality and performance) to communicate progress and drive continuous improvement
Experience participating in internal and external inspections and developing/implementing both preventive and corrective action.

Nice To Haves

Oncology experience strongly preferred
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.
Proficient in use of Microsoft products (Outlook, Excel, PowerPoint, etc.)
Ability to create and maintain power queries and v-lookups is preferred
Experienced user of GrantPlan is preferred
Thrives in a matrix environment
Able to work independently, in a fast paced environment
Has strategic thinking skills

Responsibilities

Develops and builds the US budget, site budget & language templates for Pharma & Vaccine studies.
Provides expert guidance to develop detailed specifications and negotiate content of clinical trial agreements that are robust, timely, and add significant opportunity for value generation to the business while minimizing legal, operational and financial risk to GSK during the contract life cycle.
Participates in creating and delivering solutions for simplifying work practices to increase productivity and reduce waste.
Serve as legal language subject matter expert between GSK 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 the Contractor Manager is responsible for performing due diligence checks which includes but is not limited to Fair Market Value and review of site justifications.
Determine if the contracting party’s requested changes warrant a budget and/or language escalation and to seek the appropriate approvals.
Escalate delays, impact to timelines, or risks that limit the ability to deliver a fully executed CTA within the timelines specified.
The Contract Manager should be proficient in excel and other clinical trial management tools.
Demonstrate effectiveness in both oral and written communication.
Effectively express ideas and incorporate feedback into deliverables to generate quality output.
Continuously development of knowledge of GCP, internal company guidelines, SOPs, Work Instructions, Ways of Working, new technologies and capabilities.
The Contract Manager should have experience with clinical study protocols and study timelines and milestones (i.e. SIV).
Leads and supports diverse projects and initiatives as needed.
Effectively 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 interface with GSK central study teams and business line leaders.
Drives a culture of trust, respect, transparency and accountability
As the US subject matter expert (SME) for site contracting and budgets, the Contract Manager should be able to lead and support internal and external inspections and aid in the development and implementation of preventative/corrective action plans.
Provide appropriate support to study teams and sites as needed to resolve payment issues which may include engaging with our global payment SME and our payments vendor.
Timely and accurate updating of all departmental databases and trackers.
Train and support additional staff, as required.
Ability to participate in diverse project teams, remotely.
Available and willing to travel as job requires.