Rohan Cheruvallath Thomas
Senior Clinical Data Associate
Mumbai
Summary
Clinical data manager professional offering 6+ years of success in Clinical Data Management with outstanding ability to plan, analyze and accomplish the CDM objectives in a timely manner. Extensive experience in working with Phase I through Phase III of clinical trials using EDC systems. In-depth knowledge in all Clinical Data Management phases including Study Start up, Study Conduct and Database Lockout activities and expertise in Medidata Rave, Inform 6.0 clinical databases. Strong expertise in Data Validation, Edit Check Specifications, Clinical Trial process, User Acceptance Testing, Vendor Reconciliation. Excellent Communication and Strong Collaboration skills, Proficient in working with cross functional teams and stakeholders in regard to data management activities.
Overview
6
6
years of professional experience
4
4
years of post-secondary education
Work History
Senior Clinical Data Associate
Syneos Health
Mumbai
5 2021 - Current
- 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.
- Recognized as a reliable resource within the team due to my strong analytical skills and dedication to delivering high-quality results.
- Conducted thorough quality control checks on completed datasets, ensuring the highest level of data integrity.
- Expedited study timelines through proactive identification and resolution of data discrepancies.
Junior Data Analyst
Cognizant Technology Solutions, CTS
Mumbai
2020.05 - 2021.04
- 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.
Senior Process Associate
Tata Consultancy Services
Thane
2018.02 - 2020.04
- 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.
Education
Master of Science - Biotechnology
D.Y Patil University
Navi Mumbai, India 2015.07 - 2017.05
Bachelor of Science - Microbiology
S.I.E.S College of Arts, Science And Commerce
Mumbai, India 2013.01 - 2015.04
Skills
Data management expertise
Data Validation Techniques
Data Query Resolution
Reliable team player
Adaptable
Clinical trial knowledge
Languages
English
Advanced (C1)
Hindi
Advanced (C1)
Malayalam
Advanced (C1)
Tamil
Advanced (C1)
Marathi
Advanced (C1)
Interests
Football
Music
Accomplishments
• Received one on the spot award for meeting deadlines as planned and thoroughness in every aspect of work with Quality.
• Received Monetary Award from Client For DBL achieved and met timelines as expected with Hard work and Dedication towards the Project.
• Received client appreciation for a study lock achieved with very less discrepancies for a very complex study.
Timeline
Junior Data Analyst
Cognizant Technology Solutions, CTS
2020.05 - 2021.04
Senior Process Associate
Tata Consultancy Services
2018.02 - 2020.04
Master of Science - Biotechnology
D.Y Patil University
2015.07 - 2017.05
Bachelor of Science - Microbiology
S.I.E.S College of Arts, Science And Commerce
2013.01 - 2015.04
Senior Clinical Data Associate
Syneos Health
5 2021 - Current
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