Menaka Das
@menakadas
Clinical Data Manager with 7+ years in clinical data management and clinical trial document processes under ICH-GCP.
IndiaWhat I'm looking for
I am a Clinical Data Manager with 7+ years of experience in the clinical research industry, focused on end-to-end clinical data management and clinical trial document management. I apply thorough knowledge of ICH-GCP and regulatory guidelines like Schedule-Y to support protocol-compliant study delivery.
In my current role as Clinical Data Manager ADTL at IQVIA India Pvt Ltd, I review study protocols and timelines, support Data Team Lead for end-to-end data management, and contribute to key control documents such as DMP, Data Validation Specification, and Data Transfer specification. I oversee data cleaning with minimal supervision, coordinate SAE recon and vendor data reconciliation, and support interim/final database lock readiness while identifying and escalating data risks with mitigation plans.
Previously, as Clinical Data Manager II at George Clinical India Pvt Ltd and Clinical Data Coordinator II at Quertesian Clinical Research (now Veranex), I generated study metrics and status reports, handled data queries, listing reviews, and reconciliations (Lab and SAE). Earlier, as a Clinical Record Management Officer at Syntel Pvt Ltd, I split and migrated clinical trial documents according to ICH-GCP, supported QC processes, and earned recognition through Spot Recognition Award and IQVIA Impact Award.
Experience
Work history, roles, and key accomplishments
Supports end-to-end clinical data management across the study lifecycle, including CRF review/edit checks validation and UAT. Oversees data cleaning, SAE reconciliation, database lock readiness, and escalates data risks with mitigation plans.
Clinical Data Manager II
George Clinical India Pvt Ltd
May 2023 - Aug 2024 (1 year 3 months)
Performs clinical data management activities including eCRF completion guideline support, edit check UAT setup, and query generation/closure. Conducts reconciliation (Lab/SAE), listing review/cleaning/consistency checks, and reports interim/dry run/data cut metrics.
Clinical Data Coordinator II
Dec 2019 - Mar 2023 (3 years 3 months)
Supports study setup by assisting with data review guidance and eCRF completion guideline support, including UAT for edit checks and data entry screens. Reviews and resolves data queries, performs listing review/cleaning/consistency checks, and supports Lab and SAE reconciliation plus study status/metrics reporting.
Performs supervised User Acceptance Testing (UAT), including review/generation/closure of data queries and listing reviews for accuracy and consistency. Supports lab reconciliation and other duties related to the role as directed.
Clinical Record Management Officer
Syntel Pvt Ltd
Dec 2015 - Oct 2016 (10 months)
Manages splitting and identification of clinical trial documents by standardized document types in line with ICH-GCP. Migrates documents using eTMF tooling, prepares QC logs, and supports importer corrections.
Education
Degrees, certifications, and relevant coursework
Clini India
Advanced Postgraduate Diploma, Clinical Research and Management
2015 -
Completed an Advanced Postgraduate Diploma in Clinical Research and Management in 2015.
College of Engineering and Technology (BPUT)
Bachelor of Technology, Biotechnology
2014 -
Earned a B.Tech in Biotechnology in 2014 from College of Engineering and Technology affiliated with Biju Patnaik University of Technology.
Availability
Location
IndiaAuthorized to work in
Job categories
Interested in hiring Menaka?
You can contact Menaka and 90k+ other talented remote workers on Himalayas.
Message MenakaGet matched with your dream remote job
Sign up now and join over 250,000+ remote workers who receive personalized job alerts, curated job matches, and more for free!
