Reports To: Clinical Investigator Contract & Budget Manager (Investigator Contract Management)
Education Required: AA degree (Business/Finance) or BA/BS (Business Administration/Management)
Department: Investigator Contract Management (ICM)
The Investigator Contract & Budget Associate, reporting to the Investigator Contract & Budget Manager, is responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of grants and contracts; this will also include oversight of startup activities with CRO’s;
The contract & budget associate will assume all aspects of legal document management and study metric tracking and reporting.
Essential Functions of the job:
- With limited direction, works closely with the Clinical Operations, Legal, Finance, Data Management teams to support the clinical studies’ clinical site budget and contracting needs across all phases of studies.
- Manages the day-to-day activities of multiple areas in complex clinical contracts and budget management process.
- Demonstrates an understanding of records management requirements for contract documents.
- Coordinates communication from and acts as a liaison between internal/external stakeholders regarding clinical site budget contracting
- Works on Fair Market Value (FMV) analysis and processing of FMV exceptions.
- Provides cost benchmarking for clinical budget activities using industry based system analysis.
- Active participant in various study meetings.
- Reviews and analyzes key clinical site budgets/contract and amendments, identifying areas requiring further negotiation or clarification.
- Supports the Clinical and Business Operations with data collection, analysis, and other projects as assigned.
- Prepare program/study status reports for management
- Develop and maintain tracking of negotiated savings.
- Maintains a system for tracking progress and status of clinical budget/contracts
- Provide oversight to external partners to ensure the contract lifecycle is being managed per BeiGene’s best practices and guidelines;
- Partners with external CROs to ensure that BeiGene policies/guidelines are being adhered to as external partners negotiate with potential sites to become participants in trials;
- Ensure all investigator contracts are reviewed and approved by legal prior to execution;
- Review, negotiate and approve the terms and conditions for complexed contracts in accordance with internal policy and applicable laws, as needed
- Prepare, review and submit investigator site and baseline budgets;
Support activities of various contracts and subsequent contract amendments, note to files and other contract related requests;
- Assist colleagues with the resolution of problems related to site budget, contract terms and conditions, compliance with sponsor and institutional policy, and any other contract related issues;
- Lead active/frequent communication with external partners and/or investigators and internal departments regarding research contracts throughout the contract lifecycle;
- May provide training to new ICM team members, as applicable;
- Maintain and distribute reports to internal and external partners for updates on status of assigned contracts and other activities;
- Assist with developing ICM process and process improvement guidelines
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget.
Computer Skills: Proficiency in the Microsoft Office Suite, Outlook, Word, Excel, SharePoint and Grants Manager or similar system
- Excellent communication skills (both oral and written)
- Strong interpersonal skills and professional attitude cross functionally;
- General contract and budget negotiations;
- Able to proactively identify issues and provide potential solutions for resolution;
- Detail oriented;
- Prior Global site contract and budget negotiations;
- Ability to negotiate basic and complex contract and payment terms;
- Goal and task oriented, self-starter with proven ability to work independently;
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines
- experience working with virtual teams
- Finance and/or Contract management
Travel: Estimated 1-3 times a year