Contract Manager, Clinical Site Contracts

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• 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 BeiGene Playbook to enhance the efficiency of negotiation in conjunction with BeiGene 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.

🎯 Requirements

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

🏖️ Benefits

• No specified benefits mentioned