Pfizer
Investigative Site Budgets Specialist is responsible for providing oversite for all site budget activities related to clinical trial site contracting. This includes review and periodic updates of any process and guidance documents, acting as a subject matter expert in all areas of a site budgets, overseeing compliance of site budgets during development or negotiation and acting as the final point of escalation on any site budget related issues
Role Responsibilities
- Ensure compliance with Pfizer SOP and any laws or regulations regarding investigator and clinical trial site compensation.
- Support site contracting professional and study teams in with minimal supervision in the site budgeting space by suggesting and implementing unique solutions, as needed, to achieve study goals.
- Resolve escalations of site budget requests with minimal oversight and provide solutions to complex problems when requested by site contracting professionals negotiating clinical study agreements.
- Review and propose changes to standard contract language within guidelines, particularly payment terms.
- Develop, maintain and deliver site budget training to site contracting professionals.
- Develop Per Subject Costs for high priority studies or those that require unique solutions.
- Use expert knowledge of benchmark data to problem solve and develop novel tools and process improvements
- Evaluate current and possible future policies, practices (including governmental acts and policies), trends, technology, and information potentially affecting the site budgeting space. Use this knowledge to suggest and implement improvements in this space.
- Review and provide input on relevant SOPs around site budgeting
- Contributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to achievement of business objectives at GPD or WSR Functional Line level – e.g., WSR Worldwide Safety, WSR Worldwide Regulatory Operations, GPD Clinical Development & Operations, etc.
Qualifications
Must-Have
- 7+ years of experience in clinical development operations or clinical trial outsourcing and a bachelor’s degree or equivalent.
- Significant experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities.
- Demonstrated understanding and ability to apply benchmark data to Per Subject Cost development and budget negotiations and explain the statistical significance of budget requests
- Advanced understanding of fair market value principles, global clinical trial budget requirements and nuances.
- Ability to problem solve and effectively negotiate difficult situations to reach an equitable outcome.
- Proficiency with MS Office Applications (Word/PPT) required. Expert level knowledge of MS Excel required.
- Balance of general business, compliance, finance, legal, and drug development experience.
- Precise communications and presentation skills.
- Ability to plan, identify and mitigate risks in site budgeting.
- Demonstrated ability to lead by influence rather than positional power to accomplish critical deliverables.
- Demonstrated success in working in a highly matrix-based organization.
Nice-to-Have
- 5+ years of experience in clinical development operations or clinical trial outsourcing with a master’s degree.
- 2+ years of experience in clinical development operations or clinical trial outsourcing with a Juris Doctorate (or equivalent).
- Expertise in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation.
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Global Procurement
To apply for this job please visit pfizer.wd1.myworkdayjobs.com.