Contract Manager

Job Description :

General Description :

The Contract Manager is directly responsible for the supervision of administration and negotiation processes for clinical site contracts and ensures final contracts are delivered to agreed timelines, within Fair Market Value & in compliance with relevant legal & and regulatory requirements. The Contracts Manager will identify clinical site contracts related issues and works together with other team members to propose and implement solutions.

Essential Functions of the job :

• Oversight of planning, drafting, negotiating, tracking, and execution of site / investigator contracts which may be subcontracted to an external service provider or managed internally
• Ensures final contracts are delivered to agreed timelines, within Fair Market Value & in compliance with relevant legal and regulatory requirements.
• Provide study-level oversight and guidance for clinical site contract negotiations, identify any potential risks, and be accountable for the overall contracting timelines / lifecycle in various regions.
• Serve as the study-specific point of contact with the BeiGene Clinical Operations team and legal team on-site / investigator contract and budget matters.
• Oversee a team of Site Contract Associates or equivalent at a Project level to ensure contracts in the region are completed per company standards / timelines. Implement mitigation plans as necessary in the assigned region.
• Serve as an escalation point for unresponsive sites, site budget negotiations and ensure costs are approved within BeiGene FMV standards.
• Adapts CBO’s plan and priorities to address resource and operational challenges
• Training and mentoring of new members of the local Contracts Team regarding
• financial / contractual issues and sharing experiences.
• Contribute to process improvements, knowledge transfer and best practice sharing.
• Ensure all agreements are executed in a timely manner, contributing to efficient site start-up timelines.
• Organizes and prioritizes multiple initiatives and sets clear plans for delivery
• Effectively escalate / communicate to stakeholders and clinical teams in a professional and timely manner regarding contract issues that could impact project deliverables.
• Responsible for management and administration of contracts and ensures compliance with corporate policies.
• Serve as a backup to Site Contract Associates, as needed to handle out-of-office coverage.
• Ensure proper delivery of fully executed clinical site contracts to CBO Payments teams and liaison with CBO payments team, as necessary.
• Provide substantive guidance, monitoring, and support regarding clinical site contract deliverables, including undertaking activities identified in the CBO Roles / Responsibilities and / or Study Management Plan.
• Review, apply, and maintain BeOne Playbook to enhance the efficiency of negotiation in conjunction with BeOne Legal.
• Responsible for overseeing a Clinical Research Organization responsible for contract negotiations (if applicable).
• Responsible for clinical contract management, study metric tracking and reporting.
• Active participant in various study meetings.
• Prepare program / study status reports.
• Maintains a system for tracking progress and status of clinical budget / contracts.
• 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 BeiGene policy, and any other site contract-related issues.
• Deliver training to CBO colleagues or other Business Units as needed.
• Serve as a point of escalation for sites that are unresponsive or slow to negotiate.
• Create and develop effective contract templates and tools
• Performs other duties as assigned by management.
• Works on Fair Market Value (FMV) analysis and processing of FMV exceptions (as needed).
• Provides cost benchmarking for clinical budget activities using industry-based system analysis (as needed).

Supervisory Responsibilities :

None

Qualification Required :

Education Required :

Computer Skills :

Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, Beep / Sharepoint

Other Qualifications :

Travel : Yes, 10%

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