DEEPA Muninarasimhaiah
Senior Clinical Data Manager
Bengaluru,Karnataka
Summary
Clinical Data Management professional with over 14 years in clinical research, including 9 years in CDM across CRO and sponsor environments. Managed data management activities for Phase I–III clinical trials, ensuring data quality and overseeing deliverables. Established CDM functions and standardised processes through SOPs and workflows, enhancing operational efficiency and team performance.
Overview
1
1
Language
15
15
years of professional experience
Work History
Independent CDM Freelancer
Weltrix Biometrics
Bengaluru
01.2026 - Current
- Assisted in client discovery, assessed study requirements, scoped projects, estimated resources, outlined timelines, and prepared pricing and service proposals.
- Developed SOPs, templates, workflows, and standardized operational processes to enhance CDM function.
- Coordinated EDC and clinical service provider evaluations, managed vendor qualification questionnaires, and ensured follow-up on supporting documentation.
- Evaluated clinical systems to determine their effectiveness and readiness for implementation., implementation readiness and review of vendor documentation and validation-related evidence.
- Assisted in planning resource allocation for projects to optimise efficiency., candidate interviews, onboarding, training, CDM guidance and operational process improvement.
Senior Clinical Data Manager (Lead Specialist)
Gurus CRO
Yerevan
03.2025 - 03.2026
- Established CDM function, optimised operational workflows and ensured comprehensive clinical data management throughout study start-up, conduct and closeout.
- Coordinated study deliverables and timelines, addressing outstanding issues and managing cross-functional dependencies.
- Facilitated data review, reconciliation, study documentation and ensured database lock readiness.
- Supported data quality activities, risk escalation, issue resolution and process standardization.
Senior Clinical Data Manager
Novotech
Bengaluru
05.2023 - 09.2024
- Performed Study Data Lead responsibilities across global studies, coordinating study deliverables, timelines, data quality and cross-functional dependencies.
- Coordinated interim and final database lock readiness, including query status review, reconciliation, coding checks, outstanding issue follow-up and confirmation of required deliverables.
- Monitored data cleaning progress, query aging, unresolved discrepancies and outstanding deliverables; escalated risks and coordinated corrective follow-up with cross-functional stakeholders.
- Supported protocol review, DMP development, eCRF and edit check creation/review, database build readiness, UAT, defect management and database go-live.
- Coordinated data cleaning, query management, SAE/safety reconciliation, medical coding review and third-party vendor data reconciliation.
- Generated and reviewed clinical data listings, data review reports, exception reports and study status reports, identifying discrepancies and monitoring data quality to facilitate timely issue resolution.
- Reviewed study metrics and data management reports, including query status, outstanding data, reconciliation progress and database readiness, tracking study progress against planned milestones.
- Communicated study progress, data quality concerns, reporting findings and delivery risks to relevant stakeholders, supporting timely decision-making and database lock.
Clinical Data Manager (Individual Contributor)
Alcon
Bengaluru
08.2021 - 10.2022
- Executed sponsor-side CDM activities from start-up to close-out, including protocol review, eCRF design, edit checks specification, data management plan, data transfer agreements, data review, cleaning, query resolution, and reconciliation of safety, vendor, and pharmacodynamics data.
- Facilitated data quality assurance, addressed issues, and ensured timely achievement of study milestones and completion of database close-out activities.
Clinical Data Analyst II
Covance
Bengaluru
02.2018 - 05.2019
- Performed data review, cleaning, query management, and reconciliation to maintain data integrity and accuracy in study documentation.
- Followed up on discrepancies and collaborated with stakeholders, enhancing data completeness and quality throughout the study lifecycle.
- Supported early- and late-phase clinical trials through study start-up, conduct, and closeout to ensure timely and compliant execution.
TMF Specialist
IQVIA
Bengaluru
03.2014 - 02.2018
- Managed and quality-reviewed Trial Master File documentation to ensure completeness, accuracy, consistency, and readiness for inspection.
- Identified documentation gaps and facilitated follow-up actions in accordance with TMF processes.
Clinical Research Coordinator
Bangalore Medical College and Research Institute
Bengaluru
07.2011 - 03.2014
- Coordinated site-level clinical research activities, ensuring compliance with study protocols and accurate documentation to facilitate trial operations.
Education
B.Sc and M.Sc. - Biochemistry
Bangalore University
Bengaluru, KASkills
- Clinical data management, Study Data Lead, Study closeout , DMP development , Protocol and eCRF Review ,Database build , UAT and go-live , Data cleaning , Data listings , Safety reconciliation , Medical coding review , Data reconciliation , Database lock readiness , Data quality management , KPI tracking , Vendor coordination , Resource planning , Process development , TMF management
- EDC/CDMS: Medidata Rave, Oracle RDC, Veeva Vault CDMS, Viedoc CDMS, Zelta
- Clinical data management
- Data Transfer Agreements
- TMF: EEL-C
- Veeva Vault TMF
- TMF: EEL-C,Veeva Vault TMF, Viedoc TMF and Productivity- Microsoft Office
- Guidelines: ICH-GCP E6(R3) training; familiarity with clinical data standards concepts
LANGUAGES
English, Hindi, Kannada, Telugu
PROJECT MANAGEMENT AND END-TO-END CDM EXPERTISE
- Study planning and start-up: Protocol review, DMP, eCRF and edit check review, database build, UAT, defect tracking and go-live readiness.
- Study conduct and data quality: Data cleaning, query aging, SAE reconciliation, medical coding review, DTA/DTS preparation, laboratory and vendor reconciliation, data quality issue tracking and stakeholder coordination.
- Change management: Protocol amendment impact assessment, database change requests, testing, UAT and documentation updates.
- Database lock and closeout: Lock readiness planning, outstanding query resolution, final reconciliation, coding checks, approvals and closeout documentation.
- Project delivery: Study milestone tracking, concurrent workload management, dependency monitoring, risk assessment, issue escalation, status reporting and cross-functional coordination. Including vendor contact
- Operational leadership: Resource planning, vendor qualification, SOP development, process standardization, onboarding, mentoring and project scoping.
THERAPEUTIC AND STUDY EXPERIENCE
Phase I–III Clinical Trials, Healthy Volunteer Studies, Ophthalmology, Oncology, Infectious Diseases, Gastroenterology, Medical Devices
Timeline
Independent CDM Freelancer
Weltrix Biometrics
01.2026 - Current
Senior Clinical Data Manager (Lead Specialist)
Gurus CRO
03.2025 - 03.2026
Senior Clinical Data Manager
Novotech
05.2023 - 09.2024
Clinical Data Manager (Individual Contributor)
Alcon
08.2021 - 10.2022
Clinical Data Analyst II
Covance
02.2018 - 05.2019
TMF Specialist
IQVIA
03.2014 - 02.2018
Clinical Research Coordinator
Bangalore Medical College and Research Institute
07.2011 - 03.2014
B.Sc and M.Sc. - Biochemistry
Bangalore University