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포지션 상세
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. We are searching for the best talent for Site Contract Manager.
• 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.
• 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.
• Comply with requests from QA and auditors.
• 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.
• 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.
• Exemplary customer focus with vision to drive solutions.
• 3 experience and/or equivalent competencies in pharmaceutical industry/clinical research
• Demonstrated AI literacy and an AI enabled mindset, including the ability to apply AI tools responsibly in daily work to improve productivity, decision making and quality of outcomes.
• 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
• Adhere to SOPs, ethics and departmental compliance as determined by GD management as well as operating companies, corporate, HCC and QA guidelines.
• Able to work independently as well as in a collaborative team environment.
• Fluency in English required.
주요업무
• 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.• 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.
• 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.
• Comply with requests from QA and auditors.
• 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.
• 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.
• Exemplary customer focus with vision to drive solutions.
자격요건
• Bachelor's degree in appropriate scientific or business disciplines• 3 experience and/or equivalent competencies in pharmaceutical industry/clinical research
• Demonstrated AI literacy and an AI enabled mindset, including the ability to apply AI tools responsibly in daily work to improve productivity, decision making and quality of outcomes.
• 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
• Adhere to SOPs, ethics and departmental compliance as determined by GD management as well as operating companies, corporate, HCC and QA guidelines.
• Able to work independently as well as in a collaborative team environment.
• Fluency in English required.
