Saraswathisaritha Gopu
@saraswathisarithagop
Senior clinical data professional specializing in EDC reconciliation, SAE reporting, and regulatory submissions under GCP/ICH.
IndiaWhat I'm looking for
I’m a Senior-focused clinical data professional with 9+ years of experience in Clinical Data Management and Regulatory Affairs. I’ve managed Phase ll, lll and lV clinical studies across multiple therapeutic areas, consistently ensuring on-time deliverables and high-quality work aligned with GCP and ICH guidelines.
In my day-to-day, I lead data reconciliation and discrepancy management in EDC systems such as Medidata Rave and Oracle Clinical, including eCRF (electronic Case Report Form) completion, freezing/locking, and eTMF maintenance. I generate, resolve, and track data queries, perform QC on data listings, and support edit checks through dummy data and review of edit check specifications and database specifications.
I also bring regulatory strength, preparing and coordinating submissions and working with regulatory bodies for product registration and compliance. I manage Ethics Committee coordination and documentation, communicate updates proactively to stakeholders, and train/support teams to keep study execution smooth, compliant, and audit-ready.
Experience
Work history, roles, and key accomplishments
Review and reconcile clinical trial data, raising and resolving queries for erroneous, missing, or incomplete information. Perform vendor and SAE reconciliations, manage eTMF/eCRF freezing and locking, and run QC checks and sponsor status reporting.
Clinical Data Coordinator II
ON Clinical Research
Jul 2019 - Mar 2022 (2 years 8 months)
Managed clinical data for two Multiple Myeloma studies using Medidata Rave, ensuring accurate discrepancy management and reconciliation. Conducted SAE reconciliation and query management, including GCP/ICH-compliant eCRF freezing and locking.
Clinical Data Coordinator II
DOCS Global Solutions (Subsidiary of ICON Clinical Research)
Nov 2017 - Jun 2019 (1 year 7 months)
Managed clinical data across three studies, ensuring completeness, accuracy, and consistency through computerized edits and manual checks. Performed external and SAE reconciliations, managed data queries, and handled eCRF freezing and locking to support study progression.
Junior Data Analyst
Cognizant Technology Solutions
Jun 2015 - Oct 2017 (2 years 4 months)
Performed clinical data management across four studies, managing discrepancy resolution and data reconciliation in EDC systems. Raised and tracked manual queries, troubleshot edit check issues, completed data cleaning and checks, and supported database lock along with PK/PD and laboratory reconciliation.
Clinical Research Coordinator
Memorial Centre (ACTREC and Tata Memorial Centre)
May 2014 - Jun 2015 (1 year 1 month)
Coordinated clinical study activities in compliance with protocols and local/regulatory/institutional guidelines, maintaining site master file and source documentation. Managed ethics committee submissions and approvals, SAE reporting to sponsors/ethics committee/DCGI, performed SDV/CRF activities, and supported on-site trial supplies and drug accountability.
Education
Degrees, certifications, and relevant coursework
SIES College of Arts, Science and Commerce
TYBSC, Microbiology and Biochemistry
2011 - 2014
Completed TYBSC in Microbiology and Biochemistry at SIES College of Arts, Science and Commerce (Sion, Mumbai) from 2011 to 2014.
N.G Acharya College, Chembur, Mumbai
Higher Secondary Certificate (HSC)
2008 - 2010
Completed Higher Secondary Certificate (HSC) at N.G Acharya College, Chembur, Mumbai from 2008 to 2010.
St. Xavier's College, Mumbai
Post Graduate Diploma in Clinical Research, Clinical Research
2014 -
Completed a Post Graduate Diploma in Clinical Research at St. Xavier's College, Mumbai in 2014.
Sree Narayana Guru High School, Chembur
Secondary School Certificate (SSC)
2007 -
Completed Secondary School Certificate (SSC) at Sree Narayana Guru High School, Chembur in 2007.
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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