****-** -
Ranjini
Ravindran
Clinical Data Management
Professional Summary
Clinical Data Management Professional with overall 10.5+ years of experience. Have Data
Management experience in tasks like
Discrepancy/query resolution, SAE reconciliation,
External Data reconciliation & Database edit check Testing,TMF lead etc. The responsibilities were not limited to but to ensure quality and deliverables to customer. Have supported multiple projects in
various therapeutic area and provided expertise in data management tasks. Served as Data
Operation Coordinator/Lead for multiple studies.
Work History
Sr Clinical Data Analyst
Symbiance Pharma Solutions
Prepared training slides, guidelines & SOPs.
Edit Checks drafting(vendor/lab checks).
Has coordinated & lead (DM)Study tasks. DB Spec
review.
CRF designing.
Test Scripting and UAT testing etc.
Served as Independent Data Reviewer.
Performing QC for DM tasks.
Preparation of Various study reports.
Experienced in Database tools like INFORM,
Medidata Rave, Rave X, VIDOC, RedCap
TMF review/Filing
Contact
Address
Bengaluru, KA 560035
Phone
*******.**********@*****.**
m
Skills
Project Management
Customer Service
Teamwork
Communication skills
Database
Leadership
Data analysis
2021-11 -
2022-02
Clinical Data Coordinator II
ICON Clinical Research India Pvt Ltd
External data reconciliations like IWRS
rr
Reconciliation, PK Reconciliation, and ECG
Reconciliation.
Prepared weekly status report for the Study group
& internal team.
Developing study specific specifications.
Updating and maintaining Issue logs.
Participated in study meetings and team
discussions.
Performed Listings review for clinically significant data points and issuing queries to site for
clarification.
Discrepancy management (Tracking, Generation
& Resolution of Queries).
Performed DM Review.
2021-08 -
2021-10
Sr Clinical Data Associate
Novotech Clinical Research India Pvt ltd
Performed data review,Test database and edit
specifications.
Performed data review activities for multiple
protocols, also have data entry experience in
Paper studies.
2015-04 -
2020-11
Clinical Data Specialist
IQVIA
Served as a Data Operations Coordinator (DOC)
for one protocol with less than 5 operations staff
(excludes DE) or 15+ easy to moderately complex
central laboratory studies.
served in a leadership role in a specific data
management task (e.g., tester or database
designer for technologies that don't require
extensive programming expertise) with guidance.
Served in the role of back-up to a DOC or DTL.
Conducted data review.
Write and resolve data clarifications.
Test databases and edit specifications.
Performed testing of programming.
Has understood and complied with core
operating procedures and working instructions.
Objectives were met as assigned.
Has developed and maintain good
communications and working relationships with
CDM team.
2013-03 -
2014-03
Validation Specialist I
ICON CLINICAL RESEARCH INDIA PVT LTD
Provided testing support specializing in test script execution and documentation.
Completed test execution for simple complexity
systems.
Executed formal test scripts and perform
associated documentation.
2012-08 -
2012-11
Data Management Intern
Quintiles
Performed Database Edit check testing - Inform
Platform.
2007-08 -
2011-03
Education
Bachelor of Engineering: Biotechnology
And Biochemical Engineering
University of Kerala - Thiruvananthapuram
Certifications
Good Clinical practices
Biostatistics