[Innovative Medicine] Site Contract Manager
공고 요약
원티드담당업무
회사 주도 및 연구자 주도 임상시험의 임상시험기관 계약과 부속 계약 작성, 직접 협상 및 최종화
임상시험기관 또는 계약 협상을 담당하는 CRO를 통한 계약 협상 관리
비밀유지계약, 동의서 및 기타 부속 계약 문서 협상 지원
공정시장가치 기준에 부합하는 기관 및 연구자 예산 논의 참여
계약 변경 전 과정 관리 및 법률 문서·주요 지표 추적
기관 지급 검토와 승인 지원, 연구자 연구비가 전체 연구 비용 및 준법 지침에 부합하도록 임상 운영팀 지원
품질보증 및 감사 요청 대응
임상시험기관 개시 절차의 소요 시간 단축, 비용 절감 및 효율 개선을 위한 프로세스 제안
글로벌 CCS팀 및 지원 부서와 계약 조건·예산·법률 조항의 위험 검토 및 해결 지원
자격요건 및 필요 역량
임상 개발 절차 및 임상연구 프로세스 이해
계약 협상 및 문제 해결 역량
AI 도구를 책임감 있게 활용해 생산성, 의사결정 및 결과 품질을 개선하는 역량
부서 간 협업 및 독립적인 업무 수행 능력
MS Office 및 데이터베이스 관리 지식
다량의 업무를 관리하고 대인 관계를 원활하게 유지하는 역량
표준운영절차, 윤리 및 준법 지침 준수
영어 능통
마감기한
상시채용
존슨앤드존슨 지원하기 전 이력서 Check
시간이 없다면 AI와 한번에 수정해보세요
공고 원문
소개
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.
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.
우대사항
• Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) a plus • Previous experience working in virtual teams preferred.
혜택 및 복지
자세한 사항은 홈페이지 참조
