Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more atJob Function
R&D Operations
Job Sub Function
Clinical Trial Project Management
Job Category
Professional
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job 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.
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.
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).
Education And Experience Requirements
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
Decision-Making And Problem-Solving
Previous experience working in virtual teams preferred.
Adhere to SOPs, ethics and departmental compliance as determined by GD 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, GD and operating companies.
Comply with requests from QA and auditors.Comply with requests from QA and auditors.
Able to work independently as well as in a collaborative team environment.
Other
Fluency in English required.
Travel Percentage: 10%
Required Skills
Preferred Skills:
Analytical Reasoning, Analytics Dashboards, Business Behavior, Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trials, Execution Focus, Laboratory Operations, Medical Knowledge, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics, Training Administration
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