oncology 국내 CRO, PM (임상 5년 이상)
페이지 정보
등록자 :
강대필상무
등록일 : 23-05-15 09:52
기본정보
oncology 국내 CRO, PM (임상 5년 이상) | |||
임상 | 대리~차장 | ||
무관 | 무관 | ||
서류전형 -> 1차면접 -> 2차면접 | 영어 상 | ||
2023-05-15 | 채용시 |
상세정보
본문Project Manager (임상경력 최소 5년 이상)
- Review Clinical Trial Protocols or provide operational input to Clinical Trial Protocols as required. - Select/communicate/manage other vendors to outsource clinical activities - Ensure the selection of suitable trial centers for the placement of clinical trials in their area/country, including the approval of grants. - Responsible for trial start up activities, i.e. Preparation of study documents, copyright resolution, HA submission, Drug Labeling/initial Import, and Clinical supplies checkup/import at project level - Ensure to set up proper recruitment/maintenance plan based on appropriate analysis of capability of sites selected - Ensure site initiation and training activities timely. - Update and maintain trial master file and facilitate preparation and collection of trial level documents, especially ensure all document collected prior to study initiation. - Planning and Set up trial timeline for the key metrics i.e. IRB submission, site contract, site initiation, patient recruitment, routine monitoring, close out activities. - Co-Monitoring or quality visit on status of planned versus actual patient recruitment/timeline and implement strategies to correct deviations from proposed plan according to metrics. - Assure continual GCP, ICH and applicable SOPs compliance (Informed consent process, AE and SAE reporting, CIOMS Forms, protocol, drug accountability etc.). Resolve deviations to standard by remedial action and training. - Communicate with other vendors, sponsors. - Review Clinical Study Report and follow up publication to ensure timeline - Identify project and Clinical Operations issues that will impact the successful conduct of a trial and bring to the attention of the Clinical Research Manager for information and/or resolution in a timely manner. - Establish study specific guideline such as monitoring assigned projects. - Plan studies budgets and ensure timely budget spending according to the plan and project related payment process (3rd party fee, IP cost etc.) - Purchasing process and expense clearance process for study materials, application for approval process. - Report & communicate with MFDS or other association if applicable. - Request to upload study information for each milestone in Clinicaltrial.gov. or other public sites. - Fill out the study planning form & reporting form by using study protocol. - Act as a mentor to new associates for purposes of field training, as assigned. - Work to coordinate for audits/inspection if necessary - Review Visit Report (SIV, SMV, COV etc.) - Review and approve IRB documents - Update internal/project management file - Develop & distribute project newsletter - Ensure project insourced tasks according to contract with sponsor and proceed of finance process for sponsors or other vendors. |