Job Information
J&J Family of Companies Sr. Site Contract Manager in Beijing, China
Sr. Site Contract Manager - 2406199236W
Description
Position Summary:
Responsible for preparing, negotiating, and finalizing 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.
Principal Responsibilities:
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.
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.
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.
Comply with requests from QA and auditors.
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.
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.
Exemplary customer focus with vision to drive solutions
This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.
Principal Relationships:
This position reports to Manager, Site Contracting
Internal:
- Internal Business Partners (CCS, TA, MAF, MAO, GD, HCC, Risk Management, Legal, etc.) outside parties
External:
Clinical Investigator Sites
Commercial Suppliers
Clinical Research Organizations (when applicable).
Qualifications
Bachelor’s degree in appropriate scientific or business disciplines
3 experience and/or equivalent competencies in pharmaceutical industry/clinical research
Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) a plus
Must have a working knowledge of the clinical development process with two (2) years of negotiation and contract experience
Familiarity with clinical research processes
Ability to work effectively in cross function teams
Strong and proven negotiation and problem resolution skills
Working knowledge of PCs (MS Office suite at a minimum) and database management
Must demonstrate innovative spirit, have strong interpersonal skills, and ability to manage a high volume of work
Previous experience working in virtual teams preferred.
Primary Location Asia Pacific-China-Beijing-Beijing
Organization J&J (China) Investments Ltd A- Beijing Branch (7075)
Job Function Clinical/Medical Operations
Req ID: 2406199236W
J&J Family of Companies
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