Role Summary
Budget and Contracts Manager responsible for preparing, negotiating and facilitating execution of US Clinical Site contracts and budgets for Pharma/Vaccine studies, including US budget and site budget build. Reports to the ICBP Associate Director and collaborates with ICBP, GSBC, R&D Legal, and study teams to negotiate and ensure accuracy of CTAs with proper fallback language.
Responsibilities
- Develops and builds the US budget, site budget and language templates for Pharma and Vaccine studies.
- Provide expert guidance to develop detailed specifications and negotiate content of clinical trial agreements that are robust, timely, and add value while minimizing risk.
- Participate in creating solutions to simplify work practices to increase productivity and reduce waste.
- Serve as legal language subject matter expert between internal teams and external parties on US CTA issues.
- Perform due diligence checks (e.g., Fair Market Value, site justifications) if contracting party does not proceed with initial offer.
- Determine if changes warrant budget and/or language escalation and obtain appropriate approvals.
- Escalate delays or risks affecting timely CTA execution.
- Proficient in Excel and other clinical trial management tools.
- Demonstrate strong oral and written communication; incorporate feedback into deliverables.
- Continue to develop knowledge of GCP, guidelines, SOPs, and new technologies.
- Experience with clinical study protocols and timelines (e.g., SIV).
- Lead and support diverse projects and initiatives as needed.
- Build and maintain relationships with internal and external stakeholders to add value to trials; interface with central study teams and leaders.
- Promote a culture of trust, respect, transparency and accountability.
- As US SME for site contracting and budgets, lead/support inspections and aid in preventive/corrective action plans.
- Support study teams and sites to resolve payment issues, including engagement with global payment SME and payments vendor.
- Update departmental databases and trackers in a timely and accurate manner.
- Train and support additional staff as required.
- Participate in diverse project teams, remotely.
- Available and willing to travel as job requires.
Qualifications
- 3+ years’ experience in clinical research with a Bachelor’s degree, or 5+ years’ experience with an Associate degree.
- Experience ensuring clinical trial agreements are managed and issues escalated within governance framework.
- Experience with clinical study budget benchmarking, fair market value analysis, investigator site contracting, and investigator grant payments.
- Experience with CTMS and TMFs.
- Experience analyzing trend/metrics data related to quality and performance.
- Knowledge of the clinical development process and protocol design.
- Experience participating in internal/external inspections and implementing preventive/corrective actions.
Skills
- Proficient in Microsoft Office (Outlook, Excel, PowerPoint); power queries and v-lookups preferred.
- Strong written and verbal communication; ability to influence stakeholders at all levels.
- Ability to manage multiple projects across several trials and study teams.
- Strategic thinking and ability to work independently in a fast-paced environment.
- Experience with GrantPlan is preferred.
Education
- Bachelor’s degree required for 3+ years experience; Associate degree acceptable with 5+ years of experience.
Additional Requirements
- Ability to participate in diverse project teams remotely.
- Willingness to travel as required.