Rohan Cheruvallath Thomas

• Working concurrently on multiple data management projects, and with little to no guidance from functional manager/PDM
• Understand and comply with core operating procedures and working instructions
• Perform all data validation activities
• Thoroughly understood Protocols, SOPs, DMP and all study related documents
• Discrepancy management – review, follow-up, resolution
• Produce data study metrics and present to data management team on a scheduled basis
• User acceptance script writing and testing of edit checks
• User acceptance testing for Database during study start-up.
• Database lock activities
• Prepare study reports and metrics periodically for sponsor review
• Supporting the Lead Data Manager on ad hoc request activities
• Assigning work activities among the Team members and QC of activities
• Assist with provision of data management reports in support for project team, Clinical Research Associates (CRAs), Investigative sites, Sponsor as requested
• Demonstrated/ described data review processes to sponsors and vendors as and when needed
• Assisting other managers in any other adhoc activities
• Worked on Projects with Startup Activities
• Worked on creation of eCRF completion guidelines based on study specifications.
• Prepared test scripts for programmed edit checks and UAT of all edit checks built in Rave
• Performed Activities such as Discrepancy Management, Vendor Data Reconciliation, Reporting and Closeout Activities such as freezing, Locking.
• Performed data management tasks including discrepancy review, query generation, resolution and quality control activities
• Performed ongoing data validation activity in conduct phase for assigned trials
• Performed review of Manual checks
• Study specific generation of report
• Cleaned database based upon the SAS manual listings
• Manual review of the data by pulling out reports from the standard reporters
• Carried forwarded the data issues to the Team Lead & communication within project team
• Performed Reporting activities (Missing and Overdue pages) to the sponsor
• Performed Lab reconciliation along with Pharmacokinetic, Pharmacodynamic reconciliations.
• Addressed post DBL queries from the Statistics team for minor issues.
• Developed and maintained good communications and working relationships within CDM and Cross-functional team members.
• Coordinated with site staff to address queries related to clinical data promptly, minimizing disruptions to study timelines

• Reviewing and adhering to requirements of study-specific Clinical Data Management Plans for assigned projects.
• Performing review of discrepancies (edit check) output and validation listings based on data entered into the clinical database
• Resolving answered queries correctly and re-queries where appropriate
• Reviewing and validating data in accordance with the Data Validation plan and Data Management Plan to ensure database consistency and accuracy
• Generating and reviewing of study metric reports as required by the study team
• Periodic manual reviewing of clinical trial data for discrepancies and query management.
• Completing tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload
• Proactively communicating to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts
• Participating in completion of all activities necessary for finalization and transfer of the clinical database and related project documents to the sponsor
• Assisting in tracking project progress and issuing periodic status reports
• Performing query management and discrepancy management of trial data
• Tracking and managing the status of allotted clinical trials in data management aspect
• Performing data review and query generation

Performed all Clinical Data management activities on assigned projects.

• ·Maintained clinical data accuracy through review of case report forms for completeness and consistency.
• Performed data review and query generation.
• Reviewed resolved discrepancies and closed where appropriate.
• Manual review of clinical data.
• Additionally worked as SPOC for multiple studies.
• • Additionally, I held Responsibilities of functional process Trainer.
• Gaining UAT knowledge with interaction and senior clinical data managers.
• Tracked study progress and issued periodic status reports.
• Informed responsible Lead clinical data managers of work status regularly.
• Performed vendor data reconciliation (Pharmacokinetic, pharmacogenetic and Central Lab) and to handle manual discrepancies and action the same.
• Performed locking and freezing activities whenever required.
• Escalated and assessed impact on quality issues and provide resolutions.
• Suggested updates in review and validation process to streamline study activities.
• Utilized current study documentation including protocol, Case Report Forms (CRFs), DVS, cleaning guidelines etc.
• Mentored new team members.