Hands-on Technical SME for Clinical Operations Area of expertise: Clinical early phase systems and associated study supported tools Knowledge with study set up, participant enrollment, randomization, investigational product dispensing, trial supply inventory management and participant visit tracking. Hand on experience with Evident IQ Marvin, Planisware, Almac IRT, SOCAR eSOCDAT, Clinical ink eLAS. Experience with Veeva Clinical CTMS, eTMF, and CDMS systems. Knowledge of SQL, database management, and data analysis . Familiarity with clinical data standards (e.g., CDISC, SDTM ). Experience with cloud-based solutions and SaaS platforms. Understanding of GxP, 21 CFR Part 11 , and other regulatory requirements. Statistical analysis tools SAS server, PC SAS, R studio, Qlik, CDISC tools Pinnacle 21, RYZE experience is a plus. Functional knowledge of clinical trials and correlation with clinical systems is added advantage.
Veeva RIM L1 & L2 Support Tasks General User Management Provision User access requests & update requests including inactivation and profile updates Login/SSO issues Missing notifications Troubleshooting record level access control Periodic User Dormancy Bulk data creation/update/deletion User Education Related Queries Integration Data discrepancy(Inbound/outbound sync issues, Integration job failures) Monitor scheduled jobs Object records state change request Constraints/Control Vocabulary updates Content Plan template Creation/Updates/Deletion Submission Import activities Upload submission documents using loader Content plan generation issues Troubleshooting Permission issues related to document/object records Object records state change request Configuration Picklist/value mapping updates Lifecycle/workflow updates Field visibility/layout updates DataType/Field Dependency Lifecycle Entry Criteria/Action Reporting Basic report generation Advanced report troubleshooting Audit trail extraction Flash Report config Dashboard related activities Veeva General Releases 3xs Support R1, R2, R3 releases (Testing + Documentation) Other Collaborative Authoring issues + periodic SharePoint storage checks and expansion E-signature issues Provide Troubleshoot instruction to end users on the issues they face on their daily activities Periodic SSL certificate renewals EMA gateway issues Email notifications issues MedDRA updates CV updates Migration related support Troubleshoot user not able to find document/Missing Document Incorrect field values found on the document Document not rendering Preparing and validating the loader sheets