Associate Site Contract Manager

At Johnson Johnson we believe health is everything 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 at https www jnj com Job Function R D Operations Job Sub Function Clinical Trial Project Management Job Category Professional All Job Posting Locations Mumbai India Global Clinical Operations GCO Associate Site Contract Manager CCS Title may vary based on Region or Country requirements 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 1 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 2 Provide support for negotiations in confidentiality agreements informed consent forms and other ancillary contract documents as required 3 Participate in discussions related to the development of site investigator budgets aligned with fair market value 4 Manage the contract amendment lifecycle 5 Assume responsibility for all aspects of legal document and metrics tracking 6 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 7 Comply with requests from QA and auditors 8 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 9 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 10 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 Previous experience working in virtual teams preferred Decision-Making and Problem-Solving 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