Overview:
Prepare, negotiate and finalize agreements and budgets related to clinical trials and/or overseeing a
Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team
in the pricing, planning, execution and control of site/investigator budgets and contracts.
Deliverables:
- Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc.
- Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company
sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites
or via oversite of a Clinical Research Organization responsible for contract negotiations.
Responsible for delivery on established targets/measurements.
- Work with global teams to review and analyze contractual terms and conditions. Assess legal and
budget risks in conjunction with team support functions. Partner with Healthcare Compliance,
Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution.
Escalate as appropriate.
- Analyze investigator fees in relation to fair market value pricing and ensure alignment with
regional standards and pricing guidelines. Participate in and/or lead approval escalations
as appropriate.
- Provide support for negotiations in confidentiality agreements, informed consent forms and other
ancillary contract documents as required.
- Participate in discussions related to the development of site/investigator budgets aligned with
fair market value.
- Manage the contract amendment lifecycle.
- Work with the global CCS team as necessary to review and analyze contractual terms to reach
resolution. Assess risks of budget and legal provisions in conjunction with members of the CCS
team and support functions. Escalate issues as appropriate.
- Work proactively to provide recommendations to improve processes and establish refinements
that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
- Assume responsibility for all aspects of legal document and metrics tracking.
- Provide support to review, authorize and/or understand aspects of site payments. Assist clinical
operations or clinical team in ensuring that investigator grants comply with overall study costs
and compliance guidelines.
CCS management and functional CCS support teams such as, legal, Healthcare Compliance (HCC),
Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as
appropriate.
- Track all aspects of legal document and metrics. Determine potential needs for contract
amendments and manage amendment lifecycle.
- Work proactively to improve processes and establish refinements that reduce cycle time, create
savings and improve efficiency in the initiation of clinical trial sites.
- Adhere to SOPs, ethics and departmental compliance as determined by GCDO management as
well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with
departmental and corporate processes including but not limited to the relevant processes
associated with CCS, GCDO and operating companies. Comply with requests from QA and
auditors.
- Full utilization by timely and accurate time reporting (BEACON).
- If applicable, region-specific deliverables will be specified.
- Ensures Inspection readiness by maintaining complete, accurate and timely data and essential
documents in systems utilized for trial management (e.g. SATS) according to expectations
(metrics) and archiving retention requirements.
- Ensure inspection ready and comply with relevant training requirements and developing
therapeutic knowledge to ensure service delivery.
Advanced:
o Analyze contract requests/needs from operating companies and translating into
appropriate contracts/budgets for company sponsored and investigator initiated clinical
trial agreements and other relevant legal documents as they relate to various clinical
projects. Ensure that contractual terms and provisions are following corporate process,
systems, and strategies.
o May mentor, champion, or represent functional area in process initiatives, as required.
o Autonomy with execution of CCS services.
o Depth of knowledge with CCS services.
o Process leadership.
o Region specific activities (to be specified).
Requirement:
- 2-8 years work experience, prefer with MNC background
- Clinical research experience or contract related experience in other industry with good learning ability
- English is workable, plus master the language of either Japanese or Korean at business level