POSITION SUMMARY

Responsible for preparing, negotiating, and finalizing agreements and budgets related to clinical trials. Provide support to the clinical team in the pricing, planning, execution and control of site/investigator budgets and contracts.

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. 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 life cycle.

 Work with the global C&G 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 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.

 This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.

 1- 3 years’ SSU 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

 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

 Fluency in English is required

 Must demonstrate innovative spirit, have strong interpersonal skills, and ability to manage a high volume of work

 Previous experience working in virtual teams preferred