Senior 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 comJob Function R D OperationsJob Sub Function Clinical Trial Project ManagementJob Category ProfessionalAll Job Posting Locations Bangalore Karnataka India Delhi Delhi India Hyderabad Andhra Pradesh India Kolkata West Bengal India Mumbai India Global Clinical Operations GCO Senior Site Contract Manager Global Site Contracting CCS Title may vary based on Region or Country requirements Position Summary Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting negotiating and finalizing agreements 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 grants 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 Responsible for delivery on established targets measurements Responsible for analyzing contract requests needs from operating companies and translating into appropriate contracts budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects Ensure that contractual terms and provisions are in compliance with corporate process systems and strategies Provide specialized support for negotiations in confidentiality agreements informed consent forms and other ancillary contract documents as required Analyze investigator grants for fair market value aligned with regional knowledge and the J J grant pricing guidelines and based on adequate scope of work clinical trial protocol and other clinical trial information Participate in and or lead the approval escalation of grants as appropriate Work with the global CCS team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions and communicate such to stakeholders Liaise with CCS management and functional CCS support teams legal Healthcare Compliance Risk Management Privacy and other stakeholders to obtain guidance and escalate issues as appropriate Work proactively to improve processes and establish refinements that reduce cycle time create savings and improve efficiency in the initiation of clinical trial sites Mentor and train new contract coordinators and analysts Assume responsibility for all aspects of legal document and metrics tracking Determine potential needs for contract amendments and manage amendment lifecycle 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 ContractingInternal 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 Bachelors degree in appropriate scientific or business disciplines 3 to 5 years-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 Able to work independently as well as in a collaborative team environment Other Fluency in English required Travel Percentage 10