Ref #: 33524

Employment type: Permanent - Full-Time

Location: São Paulo

Posted: 19-Nov-2021

Description

Description:

•* 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.
•* Responsible for delivery against established targets/measurements.
•* 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 C&G team as necessary to review and analyse contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the C&G 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.
•* Adhere to SOPs, ethics and departmental compliance as determined by departmental management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and appropriate corporate processes.
•* Comply with requests from QA and auditors.
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Profile:

•* Bachelor’s degree in appropriate scientific or business discipline
•* Experience and/or equivalent competencies in legal/pharmaceutical industry/clinical research
•* Excellent communication skills (both oral and written)
•* Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) a plus
•* Working knowledge of PCs (MS Office suite at a minimum) and database management
•* Fluency in English is required
•* Previous experience working in virtual teams preferred