Essential Functions of the Job:
• Prepare, negotiate, and finalize clinical trial agreements, ancillary agreements and amendments of company sponsored studies through direct communication with sites.
• Responsible for execution of contracts against planned timelines and targets.
• Manage budget grid in the contract. Ensure the cost calculation are consistent with protocol and agreed with site
• Demonstrates an understanding of records management requirements for contract documents
• Complete quality check (QC) of final approved contract and budget documents, and initiates signature process of assigned contracts to the responsible signing parties.
• Ensure final contracts are delivered to agreed timelines, within Fair Market Value & in compliance with relevant legal and regulatory requirements
• Serve as the primary point of contact between CBO and Global Clinical Operations(GCO), Legal,
• Investigator Sites and external service providers in accordance with the study related activities to meet business needs;
• Collect and maintain country and site intelligence information for each country and/or site, and prepares country/site specific contract process flows as needed;
• Forecast, set, track and communicate fully executed contract planned dates, and make all efforts to achieve the set planned date, ensuring the CM and study teams are proactively informed of changes and/or risks to the projected dates;
• Liaise with CM and BeOne Medicines legal to review and update contract template(s) as needed, including Master Clinical Trial Agreements/Clinical Trial Agreements/Project Agreements or any other Site agreement template(s);
• Liaise with CM and BeOne Medicines legal to contribute updates to the BeOne
Medicines Legal Playbook guidance document as needed;
• Liaise with Clinical Site Budgets and Payment team to ensure site contracts, including investigator site budgets, are approved and executed in accordance with CBO guidelines and BeOne Medicines policies;
• Ensure all investigator contracts are reviewed and approved by legal and/or delegate prior to execution, and in accordance with CBO and BeOne Medicines legal guidelines;
• Communicate legal and budgetary issues to internal and external parties per
department guidelines, as needed;
• Perform legal translation of contract language for Sites, as needed;
• Maintain active and regular communication with site personnel and internal BeOne Medicines partners, with regular progress tracking and updates provided throughout the contract lifecycle;
• Prepare subsequent contract amendments, note to files and other related contract documents, as needed;
• Escalates contracting issues and/or potential delays to internal and external
stakeholders, as necessary;
• Attend and actively participate in Investigator Site, project related, CBO, and other meetings, as necessary;
• Update and maintain CBO trackers with real-time updates on a regular basis, complete CBO related filing and distribution of contract documents, and maintain Contract Management System (CMS) records, in accordance with CBO and BeOne Medicines policies;
• Provides a handoff to the project/payment team upon execution of a site’s final contractual documents