Clinical Contract Manager
vor 2 Wochen
BeiGene is a rapidly growing biotechnology company with exciting opportunities for experienced professionals. We seek a highly motivated and collaborative Contract Manager to oversee the administration and negotiation of clinical site contracts. The successful candidate will ensure that final contracts are delivered within agreed timelines, within Fair Market Value, and in compliance with relevant legal and regulatory requirements.
Key Responsibilities:- Oversight of planning, drafting, negotiating, tracking, and execution of site/investigator contracts, which may be subcontracted to an external service provider or managed internally.
- Ensuring final contracts are delivered to agreed timelines, within Fair Market Value, and in compliance with relevant legal and regulatory requirements.
- Providing study-level oversight and guidance for clinical site contract negotiations, identifying potential risks, and being accountable for the overall contracting timelines/lifecycle in various regions.
- Serving as the study-specific point of contact with the BeiGene Clinical Operations team and legal team on site/investigator contract and budget matters.
- Oversight of a team of Site Contract Associates to ensure contracts in the region are completed per company standards/timelines and implementing mitigation plans as necessary in the assigned region.
- Escalation point for unresponsive sites, site budget negotiations, and ensuring costs are approved within BeiGene FMV standards.
- Functional line management of Contract Associates or equivalent and delivering individual and group feedback to support ongoing development.
- Adapting CBO's plan and priorities to address resource and operational challenges, organizing and prioritizing multiple initiatives, and setting clear plans for delivery.
- Effectively escalating/communicating to stakeholders and clinical teams in a professional and timely manner regarding contract issues that could impact project deliverables.
Requirements:
- Bachelor's degree or equivalent work experience, preferably in a health care, business, legal, or scientific discipline.
- 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.
- 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.
- Knowledge of Intellectual Property issues, Publication issues, Indemnification issues, and other standard issues of site contracts within the clinical research area.
Competencies:
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
BeiGene is an equal opportunity employer and values diversity.
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