Sr. Site Contract Manager at Johnson & Johnson in Spring House, PA
Janssen Research and Development, LLC, part of the Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for Senior Site Contract (CCS) Manager, Global Site Engagement. Candidate must have the ability to work from home 90% and travel 10%. The Sr. Site Contract Manager is 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. Principle
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. Qualifications Bachelor's degree in appropriate scientific or business disciplines 3 years-experience and/or equivalent competencies in pharmaceutical industry/clinical research Must have a working knowledge of the clinical development process with three (3) years of oncology negotiation and contract experience Familiarity with clinical research processes is required Ability to work effectively in cross function teams is required Strong and proven negotiation and problem resolution skills is required Working knowledge of PCs (MS Office suite at a minimum) and database management is required Must demonstrate innovative spirit, have strong interpersonal skills, and ability to manage a high volume of work is required Previous experience working in virtual teams preferred. Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) is preferred Adhere to SOPs, ethics and departmental compliance as determined by GCDO 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, GCDO and operating companies. Comply with requests from QA and auditors. Able to work independently as well as in a collaborative team environment.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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. Qualifications Bachelor's degree in appropriate scientific or business disciplines 3 years-experience and/or equivalent competencies in pharmaceutical industry/clinical research Must have a working knowledge of the clinical development process with three (3) years of oncology negotiation and contract experience Familiarity with clinical research processes is required Ability to work effectively in cross function teams is required Strong and proven negotiation and problem resolution skills is required Working knowledge of PCs (MS Office suite at a minimum) and database management is required Must demonstrate innovative spirit, have strong interpersonal skills, and ability to manage a high volume of work is required Previous experience working in virtual teams preferred. Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) is preferred Adhere to SOPs, ethics and departmental compliance as determined by GCDO 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, GCDO and operating companies. Comply with requests from QA and auditors. Able to work independently as well as in a collaborative team environment.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
