Deepak Singh
Open to work7 years experienceClinical Data Management Specialist
Clinical Data Management Specialist with 6+ years of experience in global clinical trials.
Standing Rank
Rank Not Available
Developer Badges
Skills & Technologies
39 skillsGitHub Activity Evidence
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Work Experience
Assoc Clinical Data Spec
Medtronic India Pvt. Ltd.
- Conducted on-site clinical training programs and supported healthcare professionals in device usage, troubleshooting, and clinical outcomes
- Assisted sales and clinical teams with product demonstrations, customer support, and engagement activities
- Participated in medical conferences and collaborated with internal stakeholders to resolve customer cases and identify growth opportunities
- Managed end-to-end clinical data management activities across study start-up, conduct, and close-out phases in compliance with GCP and ICH standards
- Designed, developed, and maintained eCRFs in Medidata Rave, including edit checks and EDC configurations
- Supported activities such as UAT of lab/IRT/coding setup, and user access management
- Performed query management, SAE reconciliation, vendor reconciliation, and discrepancy resolution to ensure data quality
- Maintained database integrity through data review, validation, and troubleshooting activities
- Acted as a key contact in study meetings, handled client escalations, and ensured timely resolution within TAT
- Maintained TMF/eTMF documentation and supported audits and regulatory inspections
Clinical DB Validation Analyst
IQVIA RDS India Pvt. Ltd.
- Managed clinical data management activities across study start-up, conduct, and close-out, ensuring compliance with GCP, ICH, and sponsor requirements.
- Designed and updated eCRFs in Medidata Rave, created and finalized edit check specifications, and maintained EDC systems per protocol and sponsor standards.
- Participated in project authorization, project planning, Rave User Acceptance Testing (UAT), validation of the Target SDV module, local laboratory and IRT setup, and development of the eCRF Completion Guide.
- Conducted query management, SAE reconciliation, vendor reconciliation (PK/PD, IVRS, lab data), manual data review, discrepancy management, and ongoing CRF/database maintenance.
- Facilitated study meetings (KOM, Sponsor Review, OSRM) as a DM contact; handled client escalations and provided timely solutions within agreed TAT.
- Reviewed and maintained TMF/eTMF documentation, ensured audit readiness, and supported audits and regulatory inspections.
- Authored and reviewed DM SOPs, training materials, and competency assessments; conducted team training.
- Conducted data troubleshooting and analysis for ongoing CRF/database maintenance to ensure accuracy and consistency.
- Utilized SQL queries to extract, review, and reconcile clinical trial data from multiple sources.
- Supported ticketing system workflows (ServiceNow), for issue tracking, resolution, and client escalations.
- Collaborated with IT teams to integrate REST APIs for data transfers between systems.
- Mentored junior team members and supported cross-functional collaboration to deliver output within timelines.
Senior Clinical Research Associate
Accenture Solution Pvt. Ltd.
- Managed clinical data management activities across multiple global trials using Medidata Rave.
- Supported study start-up activities including protocol interpretation, project authorization, project planning, Rave UAT, target SDV setup, local lab & IRT setup, coding setup, and site/user configuration.
- Designed and maintained eCRFs, edit checks, and EDC systems per protocol and sponsor standards.
- Managed query resolution, SAE reconciliation, and vendor reconciliation (PK/PD, IVRS, lab data).
- Conducted manual data review and listings review to ensure database accuracy.
- Participated in KOMs, Sponsor Reviews, and OSRM meetings; supported escalation resolution.
- Ensured TMF/eTMF completeness, audit readiness, and inspection support
- Authored and reviewed DM SOPs and training materials.
- Mentored junior team members and supported cross-functional delivery.
Projects
Projects Not Populated
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Leaderboard Standings
Leaderboard Position Pending
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Assessment Highlights
Assessments Not Completed
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AI Collaboration Score
AI Collaboration Score Pending
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Role Compatibility Profile
Role Compatibility Analysis Pending
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Achievements
Bronze Award and Grant
Winner of Bronze Award and recipient of an INR 11K grant for outstanding performance and contribution to clinical data management.
Study Startup Excellence
Recognized for leading study startup activities with zero audit findings during regulatory inspections.
About Details
Professional Bio
Clinical Data Analyst with 6+ years of experience in Clinical Data Management, study startup, conduct, closeout, and regulatory compliance. Proficient in Medidata Rave EDC, SQL, and Python, ensuring high-quality, compliant, and timely study deliverables across global clinical trials.
M.Sc. in Microbiology
Jain University, Bengaluru ( - 2019)
B.Sc. in Medical Microbiology
Dolphin PG Institute, Dehradun ( - 2017)