Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Disclaimer
Personal Information
Languages
Timeline
Generic
Sathish Kumar H

Sathish Kumar H

Chennai

Summary

Senior Lead Clinical Data Programmer with 18+ years experience in EDC programming and clinical Data management. Achievements include successful project execution through strong problem-solving and communication skills. Acknowledged for leadership and dedication in dynamic settings, driving team performance and project success.

Overview

19
19
years of professional experience
1
1
Certification

Work History

Sr. Lead Clinical Data Programming

Ephicacy Lifescience Analytics
10.2024 - Current
  • Participates in study specific database set-up and review of eCRF layout on Medidata Rave.
  • Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).
  • Builds clinical study database CRF/database screens per CRF/database Specifications provided by DM team. Creates/Programs edit checks, custom function, dynamics and derivations as per DVS.
  • Works closely with CDM QC Group to ensure all programming issues are resolved in a timely manner and study timelines are met. Completes and maintains all study documentation as per Client Process.
  • Completes study database updates as specified per Change Request documents and procedures. Trouble-shoots and solves study building issues and edit check/custom function programming issues.
  • Participate in candidate selection, conducting interviews and filling comments excel with score for the interview outcome.

Lead Clinical Data Programmer

Ephicacy Lifescience Analytics
06.2022 - Current
  • Participates in study specific database set-up and review of eCRF layout on Medidata Rave.
  • Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).
  • Builds clinical study database CRF/database screens per CRF/database Specifications provided by DM team. Creates/Programs edit checks, custom function, dynamics and derivations as per DVS.
  • Works closely with CDM QC Group to ensure all programming issues are resolved in a timely manner and study timelines are met. Completes and maintains all study documentation as per Client Process.
  • Completes study database updates as specified per Change Request documents and procedures. Trouble-shoots and solves study building issues and edit check/custom function programming issues.
  • Participate in candidate selection, conducting interviews and filling comments excel with score for the interview outcome.

Database Administrator I

ICON Clinical Research
Chennai
10.2011 - Current
  • Assist in the development, Annotation and review of CRF and edit check specifications using OC/OCRDC.
  • Review CRF content vs. global library to ensure consistency and standardization within and across databases.
  • Program Validation and Derivation Procedures using oracle PL/SQL codes for study databases.
  • Reconcile validation document against study to ensure all procedures requested are in the study.
  • Perform small to medium size ad-hoc programming tasks.
  • Coordinate QC activities of study databases and edit programming with QC Specialist.
  • Review, edit specification documents against the eCRFs and provide comments to Clinical Study Leads.
  • Perform peer review on procedures coded by other programmers.
  • Running the batch validation session queue.
  • Generate view extracts and run the data extract programs.
  • As a lead in mentoring less experienced staff includes guiding new personnel during their initial training period.
  • Chennai

Sr Clinical Data Programmer

ICON Clinical Research
Chennai
05.2019 - 06.2022
  • Participates in study specific database set-up and review of eCRF layout on Medidata Rave.
  • Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).
  • Builds clinical study database CRF/database screens per CRF/database Specifications provided by Clinical Data Programming Leads. Creates/Programs edit checks, custom function, dynamics and derivations as per DVS.
  • Works closely with centralized CDMS Validation Group to ensure all programming issues are resolved in a timely manner and study timelines are met. Completes and maintains all study documentation as per ICON procedures.
  • Completes study database updates as specified per Change Request documents and procedures. Trouble-shoots and solves study building issues and edit check/custom function programming issues.
  • Chennai

Sr Clinical Database Developer

DOCS Global (a unit of ICON Clinical Research)
Chennai
04.2017 - 04.2019
  • Leads in the development, Annotation and review of eCRF layout and corresponding database according to documented trial specific requirements using components from existing libraries.
  • Participates in study specific database set-up and review of eCRF layout on Medidata Rave.
  • Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).
  • Builds clinical study database CRF/database screens per CRF/database Specifications provided by Clinical Data Programming Leads. Creates/Programs edit checks, custom function, dynamics and derivations as per DVS.
  • Works closely with centralized CDMS Validation Group to ensure all programming issues are resolved in a timely manner and study timelines are met. Completes and maintains all study documentation as per ICON procedures.
  • Completes study database updates as specified per Change Request documents and procedures. Trouble-shoots and solves study building issues and edit check/custom function programming issues.
  • Create, test and maintain trial specific plausibility and consistency checks. Provide data transfer specifications for third party data.
  • Working extensively on development and programming related to Oncology trials.
  • Maintain and update the eCRF application and its components as required for protocol amendments or required post production changes.
  • Develop database specifications and provide support for outsourced trials. Create, file and maintain appropriate trial documentation.
  • Perform peer review of Database development, edit check programming and send peer review log to the developers.
  • Program and test procedures, of various levels of complexity, according to documented trial specific requirements, within the clinical database management system using relevant SQL, PL/SQL.
  • Update procedures as required for protocol amendments or required post production changes.
  • Understanding of Data Models and implementation for database development.
  • As a lead train/ mentor new or less experienced associates on specific task(s). Contribute in the development and maintenance of project specific libraries.
  • Chennai

Clinical Data Programmer

ICON Clinical Research
Chennai
10.2014 - 04.2017
  • Participates in study specific database set-up and review of eCRF layout on Medidata Rave.
  • Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).
  • Builds clinical study database CRF/database screens per CRF/database Specifications provided by Clinical Data Programming Leads. Creates/Programs edit checks, custom function, dynamics and derivations as per DVS.
  • Works closely with centralized CDMS Validation Group to ensure all programming issues are resolved in a timely manner and study timelines are met. Completes and maintains all study documentation as per ICON procedures.
  • Completes study database updates as specified per Change Request documents and procedures. Trouble-shoots and solves study building issues and edit check/custom function programming issues.
  • Assist in the development, Annotation and review of CRF and edit check specifications using OC/OCRDC.
  • Review CRF content vs. global library to ensure consistency and standardization within and across databases.
  • Program Validation and Derivation Procedures using oracle PL/SQL codes for study databases.
  • Reconcile validation document against study to ensure all procedures requested are in the study.
  • Perform small to medium size ad-hoc programming tasks.
  • Coordinate QC activities of study databases and edit programming with QC Specialist.
  • Review, edit specification documents against the eCRFs and provide comments to Clinical Study Leads.
  • Perform peer review on procedures coded by other programmers.
  • Running the batch validation session queue.
  • Generate view extracts and run the data extract programs.
  • Chennai

CDMS Programmer II

ICON Clinical Research
Chennai
04.2013 - 09.2014
  • Participates in study specific database set-up and review of eCRF layout on Medidata Rave.
  • Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).
  • Builds clinical study database CRF/database screens per CRF/database Specifications provided by Clinical Data Programming Leads. Creates/Programs edit checks, custom function, dynamics and derivations as per DVS.
  • Works closely with centralized CDMS Validation Group to ensure all programming issues are resolved in a timely manner and study timelines are met. Completes and maintains all study documentation as per ICON procedures.
  • Completes study database updates as specified per Change Request documents and procedures. Trouble-shoots and solves study building issues and edit check/custom function programming issues.
  • Assist in the development, Annotation and review of CRF and edit check specifications using OC/OCRDC.
  • Review CRF content vs. global library to ensure consistency and standardization within and across databases.
  • Program Validation and Derivation Procedures using oracle PL/SQL codes for study databases.
  • Reconcile validation document against study to ensure all procedures requested are in the study.
  • Perform small to medium size ad-hoc programming tasks.
  • Coordinate QC activities of study databases and edit programming with QC Specialist.
  • Review, edit specification documents against the eCRFs and provide comments to Clinical Study Leads.
  • Perform peer review on procedures coded by other programmers.
  • Running the batch validation session queue.
  • Generate view extracts and run the data extract programs.
  • Chennai

Clinical Data Programmer

Accenture Pharmaceutical Services
Bangalore
12.2009 - 10.2011
  • Assist in the development and review of CRF and edit check specifications.
  • Review CRF content vs. global library to ensure consistency and standardization within and across databases.
  • Program Validation and Derivation Procedures for study databases.
  • Perform alpha testing on the validation and derivation procedures at the time of database release as well as post-production changes.
  • Code, copy and customize procedures for a study.
  • Create technical specification document/report.
  • Reconcile validation document against study to ensure all procedures requested are in the study.
  • Perform peer review on procedures coded by other programmers.
  • Maintain the nightly batch validation queue.
  • Generate a daily batch validation report to detail the previous evening's batch statuses.
  • Review batch output on a daily basis and alert the DVAs of any data issues causing procedure errors.
  • Define and develop SDTM mapping solutions as per study requirements.
  • After data entered in eCRF by admin, generate the Views using Table Trans and Toads.
  • Define and develop standard and protocol specific productized SDTM diagrams.
  • Build domains using Table Trans by generating Oracle SQL/PLSQL scripts that convert clinical data in appropriate format using CDISC submission data standards and submit the data to FDA to load data into Clinical Data Repository, SAS generating reports using ODS.
  • After the study is ready conduct, a team meeting to ensure that it would meet the quality and perform Unit testing for all the domains of the study.
  • Coordinate QC activities of study datasets with QC specialist.
  • Give training to the new joiner and also coordinate with Quality control lead to ensure high quality on deliverables.
  • Bangalore

Clinical Data management Associate

Unithink Soft Solutions
Hyderabad
03.2009 - 09.2009
  • Responsible for eCRF Development, Edit check Programming, Creation of code lists, dependencies and restrictions, Calculation fields, eCRF form flow. Unit testing of eCRFs, edit checks using Thinkcrf and Thinktrials.
  • Maintain version control for study specific eCRFs.
  • Maintain Study specific eCRF documents.
  • Querying and export of data files using PL/SQL.
  • SQL Query and Procedure writing Skills.
  • Coordinate QC activities of study databases with QC Specialist.
  • Review, edit specification documents against the eCRFs and provide comments to Clinical Data Manager.
  • Oversee version control and revisions to Standard eCRFs as needed, with an eye toward adhering to CDISC standards as closely as possible.
  • Hyderabad

Associate Software Engineer

Trianz Life sciences (Formerly Megasoft ltd)
Chennai
02.2007 - 03.2009
  • Responsible for creation of CRF design specification document, eCRF Development, Edit check Programming, Creation of code lists, conditional fields, Derived fields, eCRF form flow. Review of edit checks specification, unit testing of eCRFs, edits checks using DWB client and Acceliant E-clinical suite.
  • Maintain version control for study specific eCRFs.
  • Querying and export of data files using PL/SQL.
  • SQL Query and Procedure writing Skills.
  • Coordinate QC activities of study databases with QC Specialist.
  • Chennai

Education

Bsc - Biochemistry

R.K.M Vivekananda college
Chennai
01.2007

Higher secondary -

Marthoma Matriculation Hr.Sec.School
Chennai
01.2004

Secondary school -

Sri Ahobila Math Oriental Hr. Sec. School
Chennai
01.2002

Skills

  • Medidata Rave/RaveX
  • Oracle Clinical 453
  • Oracle Clinical RDC 46
  • eCRF Development
  • Custom Funtion Programming
  • Quick Publish
  • R programming
  • Clinical Data Studio
  • Database management
  • SQL programming
  • Data validation procedures
  • Clinical trial operations
  • Team leadership
  • Problem solving
  • Effective communication
  • Attention to detail
  • Candidate selection

Certification

  • 2021, Integrating Python, MySQL and Tableau, Udemy
  • 2009, Clinical Data Management and SAS, Clinnovo Research Labs
  • 2009, GNIIT (Software Engineering), NIIT
  • 2007, Microsoft Certified Professional (MCP) in MS-SQL SERVER 2000, Microsoft

Accomplishments

• Rewarded Shoutout Award in Ephicacy Nov 2024 for taking complete responsibilities in overall quality and delivery excellence.
• Rewarded Cheer Award in ICON Clinical Research in 12/2021 for contribution to COVID 19 fast track trial.
• Rewarded 10 years of Service Award in ICON Clinical in 10/2021.
• Rewarded Take a Bow Award in ICON Clinical Research for taking complete responsibilities in overall quality and delivery excellence, training and mentoring new colleagues in 2019 and 05/2021.
• Rewarded Shout Award in ICON Clinical Research in delivering high quality database design and programming in 2016 and 2017.
• Rewarded ICO Award in ICON Clinical Research in delivering high quality database design and programming in 2013.
• Rewarded SPOT Award in ICON Clinical Research in delivering high quality database design and programming in 2012.
• Rewarded the Numero Uno Award in Accenture Pharmaceutical Services in ensuring process and overall quality delivery excellence in 2011.

Disclaimer

The details, furnished above is true to the best of my knowledge and belief.

Personal Information

Marital Status: Married

Languages

  • Tamil
  • Telugu
  • English

Timeline

Sr. Lead Clinical Data Programming

Ephicacy Lifescience Analytics
10.2024 - Current

Lead Clinical Data Programmer

Ephicacy Lifescience Analytics
06.2022 - Current

Sr Clinical Data Programmer

ICON Clinical Research
05.2019 - 06.2022

Sr Clinical Database Developer

DOCS Global (a unit of ICON Clinical Research)
04.2017 - 04.2019

Clinical Data Programmer

ICON Clinical Research
10.2014 - 04.2017

CDMS Programmer II

ICON Clinical Research
04.2013 - 09.2014

Database Administrator I

ICON Clinical Research
10.2011 - Current

Clinical Data Programmer

Accenture Pharmaceutical Services
12.2009 - 10.2011

Clinical Data management Associate

Unithink Soft Solutions
03.2009 - 09.2009

Associate Software Engineer

Trianz Life sciences (Formerly Megasoft ltd)
02.2007 - 03.2009

Bsc - Biochemistry

R.K.M Vivekananda college

Higher secondary -

Marthoma Matriculation Hr.Sec.School

Secondary school -

Sri Ahobila Math Oriental Hr. Sec. School

Similar Profiles

  • Yusra SwatiYusra Swati

    Clinical Data Manager at Iovance BiotherapeuticsClinical Data Manager at Iovance Biotherapeutics

  • Navneet TiwariNavneet Tiwari

    Clinical Data Programming Associate at Accenture Solution PVT LTDClinical Data Programming Associate at Accenture Solution PVT LTD

  • Nasar MohammedNasar Mohammed

    Lead Clinical Data Manager (Contract) at Regeneron PharmaceuticalsLead Clinical Data Manager (Contract) at Regeneron Pharmaceuticals

  • Sara FedorchakSara Fedorchak

    Lead Clinical Data Manager (Contract) at Dragonfly TherapeuticsLead Clinical Data Manager (Contract) at Dragonfly Therapeutics

CREATE PROFILE
Sathish Kumar H