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S

Shanmugavel S S

SDTM Annotation and eCRF Data Labeling Lead

India flagBangalore, India
Expert

Key Skills

Software

No software listed

Top Subject Matter

Clinical/Medical Data
Legal Services & Contract Review
Regulatory Compliance & Risk Analysis

Top Data Types

DocumentDocument
TextText

Top Task Types

ClassificationClassification

Freelancer Overview

SDTM Annotation and eCRF Data Labeling Lead. Brings 27+ years of professional experience across complex professional workflows, research, and quality-focused execution. Core strengths include Internal and Proprietary Tooling. Education includes Bachelor of Veterinary Science, University of Agricultural Sciences, Bangalore (1997) and Master of Science, National Dairy Research Institute, Karnal (2000). AI-training focus includes data types such as Document and labeling workflows including Classification.

Expert

Labeling Experience

Principal Statistical Programmer and SDTM Annotation Lead

DocumentClassification
Leading annotation, review, and validation of SDTM and ADaM datasets for clinical trial data. Managing and optimizing SDTM eCRF annotation practices within the organization for regulatory submission purposes. Ensuring teams follow CDISC-compliant data annotation procedures and quality standards for clinical documentation. • Providing mentorship on SDTM annotation to team members and reportees. • Conducting quality checks and compliance reviews on all annotated dataset submissions. • Enhancing systems for defining, tracking, and validating annotated datasets. • Liaising with external regulatory bodies on annotation and data labeling best practices.

Leading annotation, review, and validation of SDTM and ADaM datasets for clinical trial data. Managing and optimizing SDTM eCRF annotation practices within the organization for regulatory submission purposes. Ensuring teams follow CDISC-compliant data annotation procedures and quality standards for clinical documentation. • Providing mentorship on SDTM annotation to team members and reportees. • Conducting quality checks and compliance reviews on all annotated dataset submissions. • Enhancing systems for defining, tracking, and validating annotated datasets. • Liaising with external regulatory bodies on annotation and data labeling best practices.

2023 - Present

Lead Statistical Programmer and Data Annotation Supervisor

DocumentClassification
Supervised and contributed to annotation and preparation of SDTM and ADaM datasets for clinical trials. Oversaw annotation processes in oncology studies and ensured accuracy and compliance with data labeling standards. Validated annotated datasets for submission and implemented best practices in data labeling workflows. • Used P21 validator and internal tools for validation of annotated datasets. • Developed reviewer checklists and process documentation for SDTM annotation. • Guided teams in annotating and reviewing complex clinical data. • Ensured compliant and high-quality annotated deliverables throughout the study lifecycle.

Supervised and contributed to annotation and preparation of SDTM and ADaM datasets for clinical trials. Oversaw annotation processes in oncology studies and ensured accuracy and compliance with data labeling standards. Validated annotated datasets for submission and implemented best practices in data labeling workflows. • Used P21 validator and internal tools for validation of annotated datasets. • Developed reviewer checklists and process documentation for SDTM annotation. • Guided teams in annotating and reviewing complex clinical data. • Ensured compliant and high-quality annotated deliverables throughout the study lifecycle.

2020 - 2023

SDTM Annotation and eCRF Data Labeling Lead

DocumentClassification
Led and executed SDTM Annotation for clinical data according to CDISC standards. Worked on annotating eCRF and generating SDTM specification tables for regulatory submissions. Collaborated on the creation, validation, and quality review of SDTM domains and their associated define.xml files. • Annotated eCRF forms to link clinical data fields to SDTM variables. • Created DDT's (Data Definition Tables) in compliance with regulatory requirements. • Reviewed protocol documents, data validation manuals, and edit check lists relevant to annotated datasets. • Led workshops and provided guidance on annotation and data standards.

Led and executed SDTM Annotation for clinical data according to CDISC standards. Worked on annotating eCRF and generating SDTM specification tables for regulatory submissions. Collaborated on the creation, validation, and quality review of SDTM domains and their associated define.xml files. • Annotated eCRF forms to link clinical data fields to SDTM variables. • Created DDT's (Data Definition Tables) in compliance with regulatory requirements. • Reviewed protocol documents, data validation manuals, and edit check lists relevant to annotated datasets. • Led workshops and provided guidance on annotation and data standards.

2013 - 2020

Education

U

University of Queensland, Brisbane

Master of Information Technology, Information Technology

Master of Information Technology
2003 - 2005
K

Kriger Research Institute

Diploma in Clinical Data Management, Clinical Data Management

Diploma in Clinical Data Management
2004 - 2004

Work History

I

ICON PLC

Principal Statistical Programmer

Bangalore
2023 - Present
I

IQVIA

Statistical Programmer Scientist

Bangalore
2020 - 2023