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Regional Contracts Lead – Clinical Site Contracts
BeOne Medicines. Oversee and ensure on-time execution of regional clinical contract agreements, including CTAs, investigator agreements, confidentiality agreements, ancillary agreements, pharmacy agreements, site master service agreements, consulting agreements, single-service agreements, and subcontractor agreements .
Core Competencies
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Demonstrates expertise in managing and negotiating clinical trial agreements and budgets, with a strong understanding of compliance and regulatory matters in clinical research. Proven ability to lead teams, improve processes, and deliver results in a fast-paced environment.
ATS Keywords
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About the role
Key responsibilities & impact- Oversee and ensure on-time execution of regional clinical contract agreements, including CTAs, investigator agreements, confidentiality agreements, ancillary agreements, pharmacy agreements, site master service agreements, consulting agreements, single-service agreements, and subcontractor agreements
- Manage the regional Clinical Contracts team, including Contract Managers and Contract Associates or equivalent
- Deliver individual and group feedback to support ongoing team development
- Sign Investigator Contracts under POA when authorized by BeOne Medicines Legal and Tax
- Maintain and improve negotiation processes to meet financial and operational needs
- Ensure clinical site budget negotiations remain within fair market value and internal approval guidelines
- Partner with Clinical Operations and CBO colleagues to improve clinical site contract and budget metrics and implement processes
- Apply standards across clinical site contract and budget processes and support continuous improvement while developing TA-aligned strategies
- Serve as regional escalation point for Clinical Site Contracts and provide regional program-level oversight
- Use industry tools and data sources to provide budget and contract feedback aligned with company parameters and fair market value guidance
- Identify potential delays, provide solutions, and escalate nonperformance
- Provide oversight and guidance for clinical site contract negotiations, identify risks, and manage contracting timelines and lifecycle
- Ensure regional contracts are completed according to company standards and timelines; implement mitigation plans as needed
- Develop and implement policies and procedures based on identified needs
- Perform other tasks requested by departmental and company leadership
Requirements
What you’ll need- Bachelor’s degree; JD highly preferred or 8+ years of outstanding experience managing and negotiating clinical trial agreements and budgets
- Experience in the CRO or pharmaceutical industry is essential
- Good knowledge of ICH-GCP, pharmaceutical-related regulations and laws
- Good understanding of clinical trial contracting processes and relevant clinical operations 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
- Strong interpersonal skills, including conflict resolution and problem solving
- Proactive and positive team player; able to maintain high performance during ambiguity and change
- 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
- Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, SharePoint, etc.
- Willingness to travel 10%
Benefits
Comp & perks- Market competitive compensation package including performance-based annual bonus scheme
- Company shares (generous welcome grant!)
- In-house and external learning and development opportunities
- Fantastic benefits program
- Opportunity to work with a dynamic, collaborative, supportive, inclusive, and fun team