In this role you will be responsible for direct site facing contract and budget negotiations through contract with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies.
Primary Duties:
- Manage Clinical Contract and Nondisclosure Agreement (NDA) process for Global trials:
- Serve as a conduit between Clinical Operations and the Legal group for contract requests including Confidentiality Agreements Clinical Trial Agreements Ancillary Services Agreements Consultant Agreements and other clinical contracts
- Process all clinical contract requests and help facilitate early through the Contract Management System
- Serve as primary contact for the Client during contract negotiation phase
- Perform consistent quality audits of work output and document knowledge base as needed
- Maintain contract tracking on SharePoint site and other systems used to manage contract and budget files
Negotiate Clinical Site Contracts Budgets:
- Manage and own the contract process through its lifecycle from initial template stage to fully negotiated contract
- Work closely with study teams to develop country budget templates tailored for each study
- Negotiate and manage consistent site budgets that will assist in early site activation
- Ensure consistency in site payment schedules and terms to facilitate the payment system
- Respond to queries related to contracts and budgets
- Manage the contract escalation process to appropriate individuals as needed
- Establish good customer relations with sites starting with the primary point of contact for budgets and contracts
- Analyse contract trends using available tools and assist with developing team metrics with regard to contract timelines.
Skills and Education:
- Minimum of 3 years of global experience working in a biotech or CRO finance and/or business environment as a contract analyst/specialist
- Experience negotiating contract payment terms and budgets with UK sites is essential
- Intermediate Excel and database management skills
- Knowledge of GCP/ICH requirements
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Remote Work :
No