Clinical Data Entry

·         Data Entry Support for Non-SIP Studies/Sites - make updates in CTMS as provided on pre-validated site lists, ISIF forms, ISI change forms, and change requests received via email.  Review reference data to see if required  account/contact/address records already exist in the system.  Create new/update existing reference data as needed.  Create sites, enter site accounts and addresses, enter site contacts and addresses, assigned required external system provisioning roles,  Make updates as requested throughout the course of the study.

·         Data Entry Support for Outsourced Studies - create countries and/or sites, enter milestones and enrollment information for outsourced studies.  Make updates as trackers are received throughout the course of the study.  Follow up with sponsor project leads if trackers are not received according to agreed schedule.  Periodically run FOCUS reports and follow up with sponsor project lead to ensure errors are corrected and updates are made. 

·         Data Entry Support for Acquired Studies - create countries and/or sites, enter milestones and enrollment information for acquired studies.  Make updates as trackers are received throughout the course of the study.  Follow up with sponsor project leads if trackers are not received according to agreed schedule.  Periodically run FOCUS reports and follow up with sponsor project lead to ensure errors are corrected and updates are made.  

·         Provisioning Support for SIP Studies - assign external system provisioning roles to site contacts created in SPECTRUM through SIP integration.  Periodically run reports and follow up on missing/incorrect provisioning values

·         Reference Data Updates - create and/or update accounts, contacts, addresses as needed for study site creation or cleanup.  Review data coming into the system from outside sources and take appropriate action as required to  ensure reference data is clean and accurate.  Review data for duplicate entries and take appropriate action to remediate duplicates in reference data. 

·         Protocol Level Updates - provide support updating trial level information (study team history, protocol level accounts, etc.) as requested by the study teams.

·         Data Setup for UAT - create and/or modify data in non-production environments as requested in preparation for the execution of test scripts

·         Ad-hoc CTMS Cleanup Activities - perform manual updates in the system that result from data reviews, cleanup campaigns and periodic monitoring activities.  Run periodic reports as needed and take appropriate actions to clean/modify identified data issues.  Monitor and resolve SPECTRUM/CORE/Exostar discrepancies that impact automated provisioning process. 

For all tasks if there are any discrepancies in the information provided the CTMS DE team member will reach out to the requester, management or reference aids provided to rectify the discrepancy.