工作职责:

?Provide protocol and ICD administrative support to global Clinical Operations Study Team Leads (COSTLs) and Clinical Research Operations Managers (CROMs), including but not limited reviewing the consistency of documents, prepare RighTrack II protocol outputs report, circulate and track the approval status.

?Request set up of study team SharePoint spaces, grant access to the team and update files in SharePoint for Inspection Readiness documents including team roster changes, , updating version dates etc., and uploading of meeting minutes and any documents to SharePoint as required.

?File documents to PTMF/ GDMS.

?Maintain Pfizer Trial Master File (PTMF) in accordance with ICH-GCP and SOPs. Update the trial and site information as necessary in Corporate Clinical Trial Registry (CCTR) in a timely manner

?Assist team with the preparation of any documents upon request, including but not limited to vender oversight plan, correspondence with investigator sites and vendors, study specific manuals for the sites, etc.

?Track and update all information on an ongoing basis per request, including but not limited to site contact information, required site training attendance, vender information, patient recruitment, trial suppliers, payment schedule, Ariba orders, etc.

?Attend appropriate training programs and project teleconferences as applicable.

?Assist COSTLs/CROMs on preparing investigator meetings if required.

?Support and coordinate any activities as requested by COSTLs/ CROMs and as assigned within required timelines.

任职资格:

Preferred

?Knowledge of ICH GCP and local regulations

?Experience in management of clinical trial and/or regulatory documents

?Knowledge of application used in the clinical trials

上班地址：光谷生物城