Contract Manager, Clinical Business Operations
BeiGene
Basel
vor 6 Tg.

BeiGene 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.

Summary

As a Contract Manager, you will be working as part of contract professionals responsible for

the planning, drafting, negotiating, tracking and execution of clinical site / investigator

contracts which may be subcontracted to an external service provider or managed internally.

The Contract Manager will manage site / investigator contract negotiations on a Project Level

as well as be accountable for site / investigator contract oversight on a regional level. Regional

oversight will include management of a team of Site Contract Associates or equivalent.

Major Responsibilities :

  • 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.
  • On a project basis, lead and oversee the progress of the clinical site contracts globally.
  • 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 in accordance with company standards / timelines.
  • Implement mitigation plans as necessary in the assigned region

  • Serve as point of escalation for sites that are unresponsive or slow to negotiate
  • Serve as escalation point for site budget negotiations and ensure costs are approved within BeiGene FMV standards.
  • Serve as a back up to Site Contract Associates, as needed due 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 contracts deliverables, including undertaking activities identified in the CBO Roles / Responsibilities and Study Management Plan.
  • Review, apply and maintain BeiGene Playbook to enhance 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 trainings to clinical business operations colleagues or other BUs 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.
  • Evaluate and discuss CBO team feedback in relation with Contracting process to be applicable in future projects in Contracts optimization.
  • Supervisory Responsibilities :

  • Line Management of CBO Contract Analyst / Associates
  • Key Stakeholders :

  • Internal : Clinical Business Operations Payments, Clinical Operations, Legal,
  • Regulatory Affairs
  • External : Clinical Trial Sites, CROs and other vendors supporting Clinical Trial
  • Agreement (CTA) generation and finalization.
  • Qualifications Required :

  • 3-4 years of outstanding experience negotiating clinical trial agreements and budgets.
  • Bachelor’s degree required, degree in Law highly preferred
  • The contracting activity supported by the CBO team is fast paced, with short deadlines and quick turnaround times. Therefore, you must be capable of managing their workload and priorities to meet business requirements in a timely manner.
  • Experience in the CRO or pharmaceutical industry is essential.

    Experience :

  • Has advanced knowledge of Intellectual Property issues, Publication issues, Indemnification issues and other standard issues of site contracts within the clinical research area.
  • Has Global Site Contracting experience.
  • Excellent communications skills (verbal and written).
  • Ability to negotiate effectively with clients and sites.
  • Ability to exercise discretion and judgment while negotiating with clients and sites.
  • 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.
  • Ability to work independently, prioritize and work in a team environment is essential
  • Perform other administrative duties as assigned
  • Computer Skills : Microsoft Office apps, CTMS, Icertis, Veeva, Jira, Beep

    Other Qualifications : Strong written and verbal communication skills in English, any additional language is a plus

    Travel : Yes, 10%

    Required Competencies :

    Ethics - Treat people with respect; Inspire the trust of others; Work with integrity and ethically; Uphold organizational values.

  • Planning / Organizing - Prioritize and plan work activities; Use time efficiently; Complete administrative tasks correctly and on time;
  • Follow instructions and respond to management direction.

  • Communication - Listen and get clarification; Respond well to questions; Speak clearly and persuasively in positive or negative situations;
  • Write clearly and informatively; Effectively read and interpret written information.

  • Teamwork - Balance team and individual responsibilities; Give and welcome feedback; Contribute to building a positive team spirit;
  • Put success of team above own interests; Support everyone's efforts to succeed; Contribute to building a positive team spirit;
  • Share expertise with others.

  • Adaptability Able to adapt to changes in the work environment; Manage competing demands; Can change approach or method to best fit the situation;
  • Able to deal with change, delays, or unexpected events.

  • Technical Skills Able to assess own strengths and development areas; Pursue training and opportunities for growth; Strive to continuously build knowledge and skills;
  • Share expertise with others.

  • Dependability - Follow instructions and respond appropriately to management direction; Take responsibility for own actions;
  • Keep commitments; Commit to extended hours of work when necessary to reach goals; Complete tasks on time or communicate clearly and early when tasks are not progressing to agreed time.

  • Quality - Demonstrate accuracy and thoroughness; Look for ways to improve and promote quality; Apply feedback to improve performance;
  • Monitor own work to ensure quality.

    Analytical - Synthesize complex or diverse information; Can collect and research data; Can use intuition and experience to complement data.

    Problem Solving - Identify and resolve problems in a timely manner; Gather and analyze information skillfully.

    Project Management - Communicate changes and progress effectively; Can complete projects on time and according to approved budget.

    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.

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