oncology 국내 CRO, Sr. PM (임상 9년 이상)
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Sr. Project Manager (임상경력 최소 9년 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 & monthly KCSG status
- Develop & distribute project newsletter
- Ensure project insourced tasks according to contract with sponsor and proceed of finance process for sponsors or other vendors.
- 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 & monthly KCSG status
- Develop & distribute project newsletter
- Ensure project insourced tasks according to contract with sponsor and proceed of finance process for sponsors or other vendors.
