Contract Manager

BeiGene; United States; Remote; USD 116,000 - 157,000; Full time

Job summary

BeiGene is seeking a Contract Manager responsible for overseeing contracts for clinical sites. The role involves negotiation, compliance assurance, and team leadership in a fast-paced environment focused on fighting cancer. Applicants must have relevant experience and a strong ability to manage contract processes effectively.

Benefits

Comprehensive benefits package including Medical, Dental, Vision

401(k), FSA/HSA, Life Insurance

Paid Time Off and Wellness programs

Opportunity for equity awards

Qualifications

• 5+ years of experience in Clinical Research and/or contract/budget management
• Strong knowledge of ICH-GCP and clinical trial regulation
• Excellent written and verbal communication skills

Responsibilities

• Oversight of negotiating and executing clinical site contracts
• Ensuring compliance with legal and regulatory requirements
• Training and mentoring of local Contracts Team members

Skills

Negotiation

Interpersonal skills

Analytical Thinking

Financial Management

Problem Solving

Education

Bachelor's degree in Health Care, Business, Legal, or Scientific discipline

Tools

Microsoft Office

CTMS

Contract Lifecycle Management System

Veeva

Jira

Beep/Sharepoint

Job description

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General 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 & and regulatory requirements. The Contracts Manager will identify clinical site contracts related issues and works together with other team members to propose and implement solutions.

Essential Functions of the job:

• 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 BeOne 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 BeOne 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 BeOne Playbook to enhance the efficiency of negotiation in conjunction with BeOne 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 BeOne 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.
• Works on Fair Market Value (FMV) analysis and processing of FMV exceptions (as needed).
• Provides cost benchmarking for clinical budget activities using industry-based system analysis (as needed)

Supervisory Responsibilities:

• None
• Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, Beep/Sharepoint

Qualifications:

• Bachelor's degree or equivalent work experience; a Health Care, business, legal, or scientific discipline preferred.
• 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.
• 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.
• Proactive and positive team player. 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
• Has 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.

Travel:

• Yes, 10%

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Acts Inclusively
• Demonstrates Initiative
• Results-Oriented
• Analytical Thinking/Data Analysis
• Communicates with Clarity

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General 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 & and regulatory requirements. The Contracts Manager will identify clinical site contracts related issues and works together with other team members to propose and implement solutions.

Essential Functions of the job:

• 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 BeOne 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 BeOne 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 BeOne Playbook to enhance the efficiency of negotiation in conjunction with BeOne 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 BeOne 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.
• Works on Fair Market Value (FMV) analysis and processing of FMV exceptions (as needed).
• Provides cost benchmarking for clinical budget activities using industry-based system analysis (as needed)

Supervisory Responsibilities:

• None

Computer Skills: •

• Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, Beep/Sharepoint

Qualifications:

• Bachelor's degree or equivalent work experience; a Health Care, business, legal, or scientific discipline preferred.
• 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.
• 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.
• Proactive and positive team player. 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
• Has 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.

Travel:

• Yes, 10%

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• 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

Salary Range: $116,300.00 - $156,300.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene, Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer and we value diversity. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

About the company

BeiGene is a biotechnology company that specializes in the development of drugs for cancer treatment.

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