Contract Manager, Clinical Site Contracts

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 and 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 and 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 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 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
• Review, apply, and maintain Playbook to enhance the efficiency of negotiation in conjunction with 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 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
• 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)

Computer Skills

Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, Sharepoint etc.

Education Required

Bachelor's degree or equivalent work experience; a Health Care, business, legal, or scientific discipline preferred. Significant (at least 5 years) Clinical Research and/or contract/budget experience.

Other Qualifications

• Good knowledge of ICH-GCP, pharmaceutical related regulations and laws
• Good understanding of clinical trial contracting process, and relevant clinical operation practices
• Awareness and understanding of compliance and regulatory matters in clinical research
• Proven negotiation, interpersonal and business skills
• Strong planning and organizational skills and the ability to work independently and effectively in a dynamic environment with competing priorities
• Sense of urgency and strong goal orientation; track-record of meeting deadlines and goals
• Strong written and verbal communication including written and verbal fluency in English and local language (if not English) and interpersonal skills, including conflict resolution and problem solving
• Proactive and positive team player
• Able to maintain high performance during times of ambiguity and change in the work environment
• Experience in financial, budget, cost management/analysis, accounting, and/or financial planning skills are desirable
• Has knowledge of Intellectual Property issues, Publication issues, Indemnification issues and other standard issues of site contracts within the clinical research area
• Must be willing to work in a fast-paced environment with time-sensitive material
• Demonstrated ability to work effectively at all levels of an organization