Tamilselvan Selvaraj
Chennai
Summary
Clinical Database Management leader with 14+ years of experience in clinical data systems design, build, validation, and delivery across global clinical trials. Proven expertise in Medidata Rave, Veeva EDC, Medrio EDC, Oracle Clinical, and global library standards. Strong background in study start‑up, migrations, MSU updates, UAT, validation, audits, and cross‑functional leadership. Recognized for driving quality, compliance, and timely delivery in complex, multi‑study environments.
Overview
14
14
years of professional experience
Work History
Manager, Clinical Database Management
Precision for Medicine
Chennai
02.2024 - Current
- Lead end‑to‑end database design, build, validation, and delivery for global clinical studies.
- Oversee database build activities, edit checks, derivations, integrations, MSU updates, and migrations.
- Ensure compliance with SOPs, ICH‑GCP, CDISC standards, and regulatory expectations.
- Provide expert input on CRF design, database architecture, and EDC configuration to sponsors and internal teams.
- Act as the primary escalation point for database and system issues, driving root‑cause analysis and resolution.
- Collaborate with cross‑functional teams, sponsors, and vendors to ensure quality delivery and timeline adherence.
- Support RFP reviews, effort estimation, bid defenses, and capability presentations.
- Provide line management, mentoring, onboarding, and performance oversight for clinical database programmers.
- Conduct technical interviews and candidate assessments for Clinical Database Management and Programmer roles, supporting hiring decisions and team growth.
Principal Database Programmer
Precision for Medicine
Chennai
04.2023 - 02.2024
- Interpret protocols and translate requirements into robust eCRF designs.
- Design and maintain edit check specifications; lead internal review meetings.
- Ensure accurate role‑based access and system configuration.
- Act as SME for EDC systems and mentor junior team members.
- Proactively identify process improvements and quality enhancements.
Assistant Manager – Study Lead
Tata Consultancy Services (TCS)
Chennai
09.2019 - 04.2023
- Led database programming activities for study start‑up and post‑production phases.
- Coordinated with clients and internal stakeholders on protocol and CRF requirements.
- Assigned and reviewed work for edit check and custom function programmers.
- Supported migration activities and generated final reports.
- Trained and supported junior staff to meet delivery timelines and quality standards.
Analyst Programmer – Global Librarian
IQVIA (Quintiles)
Bangalore
03.2015 - 09.2019
- Maintained global EDC library standards across therapeutic areas.
- Designed standard forms, checks, and data elements per international CRF standards.
- Supported study build, migrations, ALS handling, and publish activities.
- Conducted impact analysis and supported post‑production updates.
- Worked extensively with Medidata Rave, Coder, Safety Gateway, and Targeted SDV.
Senior Database Executive – Study Lead
iMEDGlobal Solutions
Bangalore
04.2014 - 03.2015
- Led Oracle Clinical database programming and administration.
- Designed databases, validation procedures, derivations, and custom PL/SQL programs.
- Supported data extracts, batch data loads, and database lock activities.
Data Manager
HySynth Biotechnologies
Chennai
12.2011 - 03.2014
- Managed end‑to‑end data management activities including CRF review, database design, and validation.
- Performed discrepancy management, SAE reconciliation, and lab data handling.
- Supported UAT and database lock processes.
Education
Bachelor of Engineering - Electrical & Electronics Engineering
SKP Engineering Collage - Anna University
Tiruvannamalai06-2011
Diploma - Electrical Engineering
Vignesh Polytechnic - State Board of Tamil Nadu
Tiruvannamalai05-2006
High School Diploma -
St. Joseph’s Higher Secondary School
Tiruvannamalai05-2003
Skills
Core Competencies
Study configuration setup and user access management
Clinical Database Design & Build (EDC)
Study Start‑Up, MSU & Migration
Edit Checks, Derivations & Custom Functions
Validation (IQ/OQ/UAT) & Audit Support
Global Library Standards
Sponsor & Vendor Management
Resource Planning & Line Management
ICH‑GCP, CDISC Compliance
Technology & Tools
EDC: Medidata Rave (Certified), Veeva EDC study build (Certified), Medrio EDC (Certified), Oracle Clinical / RDC
Coding configuration: Medidata Coder and Medrio EDC
Integrations: Rave Safety Gateway, CTMS interfaces
Reporting: SAS on demand Medidata (supporting activities)
Standards: CDISC, ICH‑GCP
Languages
English
Proficient (C2)
C2
Tamil
Native
Native
Timeline
Manager, Clinical Database Management
Precision for Medicine
02.2024 - Current
Principal Database Programmer
Precision for Medicine
04.2023 - 02.2024
Assistant Manager – Study Lead
Tata Consultancy Services (TCS)
09.2019 - 04.2023
Analyst Programmer – Global Librarian
IQVIA (Quintiles)
03.2015 - 09.2019
Senior Database Executive – Study Lead
iMEDGlobal Solutions
04.2014 - 03.2015
Data Manager
HySynth Biotechnologies
12.2011 - 03.2014
Bachelor of Engineering - Electrical & Electronics Engineering
SKP Engineering Collage - Anna University
Diploma - Electrical Engineering
Vignesh Polytechnic - State Board of Tamil Nadu
High School Diploma -
St. Joseph’s Higher Secondary School