Contract Manager, Clinical Business Operations
Vor 2 Tagen
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.
- 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
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