Contract Manager at BeiGene | Sydney | Rezi

Contract Manager at BeiGene

Contract Manager

BeiGene · Sydney

5 days ago

Contract Manager

BeiGene · Sydney

6 days ago
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About the Role

The Contract Manager is responsible for overseeing the administration and negotiation of clinical site contracts, ensuring timely delivery, adherence to Fair Market Value, and compliance with legal and regulatory requirements. This role involves identifying and resolving contract-related issues, providing study-level guidance, and managing a team of Site Contract Associates.

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 & in compliance with relevant legal and regulatory requirements.
  • Provide study-level oversight and guidance for clinical site contract negotiations.
  • Identify potential risks and be accountable for 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 to ensure contracts are completed per company standards/timelines.
  • Implement mitigation plans as necessary in the assigned region.
  • Serve as an escalation point for unresponsive sites and site budget negotiations.
  • Ensure costs are approved within BeiGene FMV standards.
  • Functional line management of Contract Associates or equivalent and delivers individual and group feedback.
  • 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 regarding contract issues.
  • Responsible for management and administration of contracts and ensures compliance with corporate policies.
  • Serve as a backup to Site Contract Associates for out-of-office coverage.
  • Ensure proper delivery of fully executed clinical site contracts to CBO Payments teams.
  • Provide guidance, monitoring, and support regarding clinical site contract deliverables.
  • Review, apply, and maintain BeiGene Playbook to enhance negotiation efficiency.
  • 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 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.
  • Assist colleagues with the resolution of problems related to site budget, contract terms and conditions, and compliance.
  • 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.
  • Provides cost benchmarking for clinical budget activities.
  • Develop and maintain tracking of negotiated savings as it relates to investigator budgets.
  • Present initiatives to improve team performance effectively.

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.
  • 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.

Skills

  • Microsoft Office apps
  • CTMS
  • Contract Lifecycle Management System
  • Veeva
  • Jira
  • Beep/Sharepoint
  • Negotiation
  • Interpersonal skills
  • Business skills
  • Planning
  • Organizational skills
  • Written communication
  • Verbal communication
  • Conflict resolution
  • Problem solving
  • Financial analysis
  • Budget management
  • Cost management
  • Accounting
  • Financial planning
  • Intellectual Property issues
  • Publication issues
  • Indemnification issues

Location

  • Basel
  • Beijing
  • Cambridge, U.S.

Work Type

  • Contract
  • Full-time

Experience Level

  • At least 5 years

Education Level

  • Bachelor's degree or equivalent work experience

Salary/Compensations

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

Benefits

  • Company shares (generous welcome grant!)
  • In-house and external learning and development opportunities
  • Fantastic benefits program and keep improving!

About the Company

  • BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide.
  • With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations.
  • We are committed to radically improving access to medicines for far more patients who need them.
  • Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S.
  • 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.

Equal Opportunity

  • BeOne 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 BeOne’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 BeOne.
  • For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/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) BeOne’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) BeOne’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.