Clinical Contract Manager

1 week ago


Australia BeiGene, Ltd. Full time

Job Summary:

The Clinical Contract Manager will be responsible for the supervision of administration and negotiation processes for clinical site contracts. This role will ensure that final contracts are delivered to 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.
  • Ensures final contracts are delivered to agreed timelines, within Fair Market Value, and 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 BeiGene Clinical Operations team and legal team on site/investigator contract and budget matters.
  • On a regional level, oversee a team of Site Contract Associates to ensure contracts in the region are completed per company standards/timelines.
  • Serve as an escalation point for unresponsive sites, site budget negotiations, and ensure costs are approved within BeiGene FMV standards.
  • Functional line management of Contract Associates or equivalent and deliver individual and group feedback to support ongoing development.
  • Adapts CBO's plan and priorities to address resource and operational challenges.
  • 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 BeiGene Playbook to enhance the efficiency of negotiation in conjunction with BeiGene 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.
  • Collect site-specific contract/budget information and contribute to the maintenance of contract/budget intelligence tools.
  • 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 BeiGene policy, and any other site contract-related issues.
  • Deliver training to CBO colleagues or other Business Units as needed.
  • 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).
  • Develop and maintain tracking of negotiated savings as it relates to investigator budgets.
  • Present initiatives to improve team performance effectively.

Supervisory Responsibilities:

  • Line Management of CBO Contract Analyst/Associates (or equivalent).

Qualification Required:

Education Required:

  • 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.

Computer Skills:

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

Other Qualifications:

  • 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%

What we offer to our valued employees:

Market competitive compensation package including performance-based annual bonus scheme.

Company shares (generous welcome grant and performance-based annual equity plan).

Full-time working from home.

In-house and external learning and development opportunities.

Fantastic benefits program as per the current policy including:

  • Personal health insurance reimbursement.
  • Home-office setup allowance.
  • Monthly reimbursement for home office expenses (i.e., internet, mobile).
  • Group life insurance & income protection insurance.
  • Wellness benefits (Employee Assistance Program).
  • Paid parental leave.
  • And more as the benefit programs keep improving.

Plus you get to work with a dynamic team of collaborative, supportive, diverse, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

BeiGene is proud to be an Equal Opportunity Employer:
We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity, and Driving Excellence, 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 is committed to respect and protect personal information rights of job applicants and will process job applicants' personal information in accordance with applicable laws and regulations.

Due to BeiGene's global operation, job applicants' data will be stored overseas with adequate protection. Besides, job applicants' data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeiGene. For further details, please refer to BeiGene's Job Applicant Privacy Policy (

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeiGene's Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeiGene's Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.

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