Contract Manager, Clinical Site Contracts

🔥 39 minutes ago

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Logo of BeOne Medicines

BeOne Medicines

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

• 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 & regulatory requirements. • Oversight of planning, drafting, negotiating, tracking, and execution of site/investigator contracts which may be subcontracted to an external service provider or managed internally. • 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. • Organizes and prioritizes multiple initiatives and sets clear plans for delivery. • Responsible for management and administration of contracts and ensures compliance with corporate policies.

🎯 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. • 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. • 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. • Experience in financial, budget, cost management/analysis, accounting, and/or financial planning skills are desirable. • 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.

🏖️ Benefits

• Flexible working hours • Professional development opportunities

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