Note: The job is a remote job and is open to candidates in USA. The hiring client is confidential. The Clinical Trial Contract Manager oversees clinical trial site budgets and contracts, including fair-market-value assessments, site fee framework maintenance, and timely administration of site payments.
Responsibilities
- Prepares, negotiates, and executes a variety of agreements
- Reviews contract language and prepares responses to negotiate contract modifications
- Maintains contract files and systems
- Maintains close working relationship with all Clinical Operations as well as Legal, Ethics & Compliance and Clinical Development & Medical Affairs (CDMA)
- Ability to build clinical trial site budget and ensures it is of high quality and allocations are within fair market values (FMV); analyze protocol flowcharts to create costing, payment strategies, and budget estimates and negotiation prameters within FMV
- Drives development and maintenance of Site Fee Framework
- Sets up, closes, re-opens, and submits payments within all grants
- Effectively uses budget-specific and trial metrics and tools to report on, provide visibility into, and analyze performance and deliverables
- Maintains a focused continuous improvement culture by identifying and executing strategies and priorities to enable the Budget group to deliver value and enhance overall operational effectiveness
- Actively remains current with industry standards, trends, and competitive intelligence on budget best practices
- Interfaces across Medical, all TAs, Finance, Legal, and external parties e.g., investigators, site personnel, third party vendors
- Liaises within Clinical Trial Manager and TA Lead for review and approval of budget
- Liaises with Clinical Finance/Accounting Department, Legal Department (if needed) and the local Head of Clin Ops and/or Clinical Operations Management for approval of payment related decisions (e.g., standard payment frequency) and maintain proper documentation
- Represents Contract/Budget group processes on local/global working groups
- Ensures commitment to customer-centric behaviors
- Maintains high degree of responsiveness to both internal and external requests
Skills
- Strong clinical background and budgeting understanding of cost drivers and benchmarks for clinical site budget
- Ability to think strategically and initiate strong and persuasive contractual arguments to support business policies and objectives
- Track record in setting priorities, organization and problem-solving skills which support and enable sound decision making
- Excellent customer service skills and high attention to detail
- Demonstrated analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutions
- Excellent written and verbal communication skills and the ability to be clear and concise in a variety of communication settings
- Experience in working with systems, applications related to clinical and/or project management planning and reporting systems
- Excellent knowledge of computer applications (Excel, Word, Access) is essential
- Knowledge of Veeva is a plus
- Bachelor's degree with minimum of five (5) years of relevant business experience in regulated pharmaceuticals or healthcare industry
Benefits
- Remote work
- Support for a healthy working environment, meaningful work, mobility, networking, and work-life balance
Company Overview