Contract Manager, Clinical Site Contracts

🔥 25 minutes ago

🇺🇸 United States – Remote

💵 $118.6k - $158.6k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

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 the 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

• Supervise administration and negotiation processes for clinical site contracts • Plan, draft, negotiate, track, and execute site/investigator contracts • Ensure contracts meet timelines, Fair Market Value, legal, regulatory, and company requirements • Provide study-level oversight and guidance for clinical site contract negotiations • Identify risks and manage the overall contracting lifecycle across regions • Serve as study-specific point of contact for Clinical Operations and Legal teams • Oversee Site Contract Associates or equivalent at the project level • Implement mitigation plans and escalate unresponsive sites and budget negotiations • Train and mentor Contracts Team members • Contribute to process improvements, knowledge transfer, and best-practice sharing • Ensure timely execution and delivery of contracts to support site start-up • Communicate contract issues affecting project deliverables to stakeholders and clinical teams • Manage and administer contracts in compliance with corporate policies • Provide coverage for Site Contract Associates as needed • Deliver executed contracts to CBO Payments teams and liaise with payments teams • Provide guidance, monitoring, and support for clinical site contract deliverables • Review, apply, and maintain the BeiGene Playbook with Legal • Oversee Clinical Research Organizations responsible for contract negotiations, if applicable • Track study metrics and report clinical contract status • Participate in study meetings and prepare program/study status reports • Maintain systems tracking clinical budget and contract progress • Support amendments, notes to files, and other contract-related requests • Resolve site budget, contract-term, compliance, and related issues • Deliver training to CBO colleagues and other Business Units • Create and develop contract templates and tools • Perform Fair Market Value analysis, process exceptions, and provide cost benchmarking as needed • Perform other duties assigned by management

🎯 Requirements

• Bachelor's degree or equivalent work experience; a Health Care, business, legal, or scientific discipline preferred • At least 5 years of Clinical Research and/or contract/budget experience • 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; 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 fluency in English and local language (if not English) • Interpersonal skills, including conflict resolution and problem solving • Experience in financial, budget, cost management/analysis, accounting, and/or financial planning skills are desirable • Knowledge of Intellectual Property, Publication, Indemnification, and other standard clinical site contract issues • Willingness to work in a fast-paced environment with time-sensitive material • Demonstrated ability to work effectively at all levels of an organization • Ability to travel 10% • Proficiency with Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, and SharePoint

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness benefits • Reasonable accommodation for applicants with disabilities

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