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BeOne

Global oncology therapeutics discovery, development, manufacturing

Senior Contract Associate Lead

Contract ManagementConfirmed live in the last 24 hours
Full-timeJapan

About the Job

Requirements

  • A bachelor's degree or relevant experience is required.
  • Four years of outstanding experience negotiating clinical trial agreements and budgets are required.
  • Proficiency with Microsoft Office applications, clinical trial management systems, contract lifecycle management systems, Veeva, Jira, and SharePoint is required.
  • Knowledge of ICH-GCP, pharmaceutical-related regulations and laws is required.
  • Understanding of the clinical trial contracting process and relevant clinical operations practices is required.
  • Awareness and understanding of compliance and regulatory matters in clinical research are required.
  • Negotiation, interpersonal, and business skills are required.
  • Planning and organizational skills, along with the ability to work independently and effectively amid competing priorities, are required.
  • Written and verbal fluency in English and the local language, if that language is not English, is required.
  • Written and verbal communication skills, including interpersonal skills, conflict resolution, and problem solving, are required.
  • Knowledge of intellectual property, publication, indemnification, and other standard clinical research site-contract issues is required.
  • The ability to work in a fast-paced environment with time-sensitive material is required.
  • The ability to work effectively at all levels of an organization is required.

Responsibilities

  • Independently review, draft, and negotiate complex clinical site contracts and prepare or review complex requests related to clinical business operations.
  • Serve as the primary resource for complex agreements and contracts across a variety of agreement types.
  • Lead regional oversight of contract amendments and oversee regional execution of site contract amendments by other Contract Associates.
  • Serve as the primary contact between Clinical Business Operations and Global Clinical Operations, Legal, sites, and external service providers for study-related activities.
  • Serve as the primary site-contracts lead at the protocol level when assigned.
  • Prepare and document process flows for each study.
  • Draft, review, and analyze site and investigator contracts.
  • Negotiate and finalize, or assist in negotiating and finalizing, clinical trial and services contracts with the Legal Department, study teams, investigators, and clinical sites; amend and terminate contracts as needed.
  • Manage the execution and signature process for contracts with sites, investigators, and other project-related parties.
  • Plan and forecast site-contract execution dates and communicate projections to Clinical and Study Start-up teams.
  • Work with the team to review deliverables and identify key errors to maintain consistent work quality.
  • Liaise with Legal to review and update contract templates, including MCTA, CTA, PA, and ancillary agreement templates.
  • Liaise with Legal to review and contribute updates to legal Playbook guidance documents.
  • Liaise with the Investigator Payments team to ensure site contracts, including investigator grants, are executed in accordance with payment guidelines.
  • Ensure investigator contracts are reviewed and approved by Legal or a delegate before execution.
  • Revise legal contracting text using the Playbook process and escalate revisions in accordance with Clinical Business Operations and Legal guidelines.
  • Communicate and explain legal and budgetary issues to internal and external parties under department guidelines.
  • Translate and proofread contracts with clinical sites and investigators as needed.
  • Maintain frequent communication with external partners, investigators, and internal departments throughout the contract lifecycle.
  • Assist in developing investigator baseline budgets as needed.
  • Prepare contract amendments, notes to files, and related contract materials as needed.
  • Escalate issues to internal and external stakeholders as necessary.
  • Participate in project-related meetings.
  • Develop and manage status trackers, prepare start-up and close-out documentation, and maintain contract-management system records.
  • Hand off executed final site-contract documents to the project and payment team.
  • Collect site-specific contract and budget information and contribute to maintaining contract and budget intelligence tools.
  • Assist with training new Clinical Site Contracts team members on Clinical Business Operations processes and systems.
  • Assist Clinical Site Contracts management with developing and implementing initiatives and negotiation and execution processes.
  • Provide training on clinical site contractual requirements and negotiation.
  • Mentor and train junior-level staff.

Desired Qualifications

  • Experience in financial, budget, cost management or analysis, accounting, or financial planning is desirable.

About the Company

BeOne

Global oncology therapeutics discovery, development, manufacturing

BeOne Medicines discovers, develops, and commercializes oncology therapies worldwide, focusing on hematologic cancers and solid tumors. Its products work by leveraging internal R&D and clinical development to bring therapies to market quickly, with Brukinsa serving as a leading backbone in the US and European markets. It differentiates itself through a large-scale global clinical network and cost-efficient development and manufacturing that support high margins and a focus on large-market cancer indications. Its goal is to expand access to high-impact, affordable cancer treatments across more than 45 countries while growing its pipeline into immunology and solid tumors.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Dongcheng District, China
Founded
2010

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