[한국화이자제약] Established Product BU/ Medical Research Associate (1yr)
Key Responsibilities
[1] IIR & PSR Coordination
· Manages the whole operational process of IIR and PSR.
· Proactively communicates with the investigators regarding the operational aspects of IIR/PSR.
· Arranges local review committee (LRC), drafts meeting minutes, sends approval or declination letter to investigator and archives the documents in the system.
· In review process, keeps constant contact with the global IIR Manager.
· Once the IIR proposal is forwarded to the GRC (Grant Review Committee), attends the GRC in collaboration with MM
· After the approval of IIR, if needed, oversights the whole study drug order and delivery process
· Manages contract processing including preparing FCPA documents, drafting contracts, communicating with site’s contract reviewers
· Requests payment based on the payment schedule in the contracts and keep the records
· Periodically sends out the study status update form to the investigators to check the status of the study ; updates regularly to the global IIR Management System
· When the publication/amendment is locally reviewed by MM, supports the documentation using the standard template
· Tracks local IIR budget status by product and plans the budget estimation.
· Confirms the submission status for PSR and tracks the global review progress in the system after local review and checks the receipt status of raw material by sites.
· Submits the IIR/PSR in the KRPIA online reporting system according to KRPIA clinical activity guidelines
[2] BE study management
A. Project Management
Study Design
· Provides support to BE CROs to develop study documents which are Core Protocol Element (CPE), protocol, Case Report Form (CRF), Informed Consent Document in consultation with Study Team which includes Pharmacologist, Clinical Lead, Clinician, Statistician and Clinical Protocol Manager (CPM).
· Responsible for clinical supply forecasts for BE studies in consultation with Clinical Supply Coordinator (CSC).
Study Placement
· Supports for BE CROs selection in consultation with EPBU Medical Director and support CRO audit if necessary.
· Oversight BE CROs to select qualified sites for BE studies.
Study Start-Up
· Responsible for regular update of study status if necessary (e.g. RighTrack II).
· Develops a detailed project plan with clear milestones & responsibility allocation and risk management strategy in consultation with Study Team.
· Responsible to develop Clinical Trial Application in collaboration with Regulatory Affairs.
· Responsible for developing supplementary Clinical Trial Application filings in collaboration with Regulatory Affairs.
· Responsible for verifying accuracy of translations of essential documents (e.g. Protocol).
· Responsible for developing budgets and contracts for the responsible BE CROs and other vendors.
· Responsible for clinical supply related communication with CSC.
Study Conduct
· Responsible for preparing regular project update reports for Study Team and other related functions
· Ensures appropriate vendor oversight as per oversight and communication plans in consultation with CTSC.
· Keeps a track of clinical supply handling by CSC.
· Responsible for payment to BE CROs and vendors in a timely manner.
· Responsible for study specific trouble shooting in consultation with EPBU Medical Affairs Director and Study Team.
· Ensures project for Audit/Inspection readiness.
Study Close-Out
· Provides support to BE CROs in writing clinical study report.
· Responsible for TMF management of BE studies.
B. Site Management
· Responsible for oversight BE CRO to ensure site monitoring is conduct per global/local guidance and regulation.
· Oversight BE CROs in reporting of safety events from the sites and support Drug Safety Unit to get additional information and resolve safety queries as needed in collaboration with BE CROs.
· Responsible for conduct monitoring for BE CRO to ensure the tasks done by CRO is conducted per Pfizer standard, SOPs and local regulation.
[3] PMS management
· Responsible for delivering potential study sites to CRO in consultation with medical manager
· Communication with alliance partner and subcontracted CRO regarding overall PMS operations
· Checks the important PMS milestones and reports the progress & issues to medical manager & MAD
Requirements
§ Bachelor degree above (background in the bioscience - veterinarian, pharmacy or postgraduate level science degree is preferred)
§ Pharmacist preferred
§ Understanding on scientific and medical publications
§ Full-scale knowledge of Pfizer SOPs on Clinical Research and FCPA
§ Minimum 1~2 yrs of relevant working experience (e.g. Clinical Research Associate) is required
§ English communication both in written and spoken formats
§ Skills in documentation and archiving
제출서류: https://www.linkedin.com/jobs2/view/10027323?trk=jobs_jig_jobs
국/영문 이력서 및 자기소개서(자유양식)/ 개인정보처리동의서
*(각종 증빙서류는 서류전형합격자에 한해 추후제출)
접수방법:
- 지원사이트(위 링크) 로그인 후 화면 하단 또는 우측 상단 Apply on company website 클릭 -> 파일첨부 -> 접수 완료
- 위 경로로 지원이 되지 않으실 경우(koreatalentacquisition@pfizer.com)으로 문의 부탁 드립니다.
※(https://www.linkedin.com/jobs2/view/10027323?trk=jobs_jig_jobs)을 통한 지원 이외의 이메일 및 우편접수 등은 받지 않습니다.
서류마감기한: 12월 31일(화)까지
개인정보처리동의서(입사지원자용).doc