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채용공고

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PMS Project Manager 채용
채용구분 경력 고용형태 정규직
근무지 서울 모집인원 0명
채용부문 PMS PM
상세내역
  • - Maintains ability of RMP relevant activities; prepares local RMP documents including RMP mandated studies; participates or organizes local RMP implementation meeting if applicable, and shares RMP activity status with relevant relevant functions internally, shares RMP activities with HQ and required parties (sharing AE reporting cases, periodic report submission status, any issue findings, local RMP relevant regulations. etc)
  • - Abilities to do back-up handling of ICSRs (if requested, SUSARs reporting, AE training back-up, product based request from HA or HQ, reconciliation between safety databse and clinical database, safety reporting plan review, etc)
  • - Maintain ability for understanding PMS and observational study related regulation and SOPs and application on studies and experienced on PMS or observational study
  • - Maintains timely and effective communication among cross-functional team members and CROs if necessary, site staffs; Attend medical staff meetings, project team meetings, teleconference with oversea colleagues, and internal or external clinical training session according to the project communication, training plans
  • - Abilities to identify potential issues and implement corrective actions independently.
  • - Maintain Issue finding and problem solving skills, seeking guidance as needed. Demonstrates effective conflict resolution
  • - Responsible for CRO management: monitors all types of clinical studies; may participate in all types of site visits with CROs; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations; accountability of study-related materials; regularly reviews the status of study status; maintain effective time management skills; may present materials, as requested; manages with the preparation of study start-up materials and tools with CROs, as requested.
  • - Completes and submits reports according to SOPs or local regulations.
  • - Maintains awareness of key study performance indicators for studies, Updates study and patient status information. Tracks Investigator payments/milestones.
  • - Manages essential documents (protocols, ICF, and CRFs. etc) preparation and review process with CROs and headquarter if requested; may amend essential documents based on regional office or HQ's comments, well-communicated with regional project leader.
  • - Manage study budget and outsourcing vendors' fee or study-related fees timely
지원자격
  • - Bachelor’s Degree of University
  • - Pharmacist or nurse or major in scientific field is preferred
  • - Minimum 7 years of project management experience in PMS or phase IV studies in CRO/Pharma industry
  • - Must have full cycle experience (mandatory)
  • - Late Phase trial or/ and PMS experience is mandatory
  • - Understanding Re-examination related regulations and SOPs and application on study
  • - Experience on Re-examination study (Understanding of Protocol, CRF, ICF medical records, data management, statistics)
  • - Effective written and verbal English communication skills
  • - Proactive, Interpersonal, decision-making and issue resolution skills are required
  • - Good communication, negotiation and presentation skill
  • - Comprehensive knowledge of clinical development process and relevant regulations (e.g., GCP, SOP, local regulations)
제출서류
  • [기본]
    ▸ 자격증 사본(해당자에 한함)
  • ▸ 국가보훈대상자는 취업지원 대상자 증명서 제출
  • ▸ 장애인 대상자는 장애인 증명서 제출
  • [필수] ▸ 최종학교 졸업증명서 및 성적 증명서
  • [필수] ▸ 이력서에 기입 된 재직(경력)증명서 전체
  • [필수] ▸ 영문 CV

※제출서류는 지원서 제출시 첨부파일로 제출

채용절차 1차 (서류전형) → 2차(면접)→ 3차(최종면접) → 건강검진 → 최종합격통보 → 채용
접수방법 당사 홈페이지에서 온라인 입사지원 https://recruit.astellas.co.kr
서류접수기간 ~2020.01.22(수) 23:00까지
문의처
주의사항
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