Aravinthan Annamalai
Associate Manager, Clinical Data Management
Tenkasi
Summary
Database programmer possessed 10 years of experience in clinical trials database design on study setup using tools like Medidata Rave, MEDRIO and Veeva Vault and 2 years 2 months of experience as UAT manager along with comprehensive knowledge and good experience in CSR submissions and SDTM annotations.
Overview
12
12
years of professional experience
6
6
years of post-secondary education
2
2
Languages
Work History
Associate Manager - Clinical Data Management
VERANEX
1 2023 - Current
- Manage team of professional data management staff as per Organization policies, procedures, and applicable regulations.
- Plan and prioritize resource allocation across projects.
- Responsible for optimal utilization of staff.
- Responsible for database validation group in data management and ensure all UAT activities are carried out per timelines and Standard Operating Procedures.
Assistant Manager - Clinical Data Management
VERANEX
01.2022 - 12.2022
- Manage team of professional data management staff as per Organization policies, procedures, and applicable regulations.
- Plan and prioritize resource allocation across projects.
- Responsible for optimal utilization of staff.
- Responsible for database validation group in data management and ensure all UAT activities are carried out per timelines and Standard Operating Procedures.
Team Lead-Subject Matter Expert EDC
QUARTESIAN (AQUIRED BY VERANEX IN JUNE 2021)
01.2020 - 12.2021
- Adherence to timelines for all deliverables and milestones including Data-base deployment scope.
- Monitor team members' participation to ensure training are being provided is being put into use, and to see if any additional training is needed.
- Perform quality control (QC) checks on electronic submission documents to meet FDA and client specifications.
- Perform new EDC Tools evaluations.
- Provide technical assistance to Project Teams and Sponsor on EDC tools related questions
Senior Clinical Database Programmer
Quartesian Clinical Research Pvt.ltd
01.2017 - 12.2019
- Independently perform all Study Initiation Activities.
- Ensure activities have been performed as per SOP.
- Review protocol and get it clarified if any incosistants on protocol.
- Develop specifications, create database, test the database, program edit checks, prepare test data for edit check specification, test edit checks and annotate SDTM CRF.
- Utilize primary development tools such as but not limited to Medidata Rave, Open Clinica, Medrio, SAS and other supporting tools.
- Also, technical support as subject matter expert for these tools.
Clinical Data Coordinator II
Quartesian Clinical Research Pvt.ltd
06.2014 - 12.2016
- Study initiation activities.
- Keep on tracking of all updated study related documents and mails.
- Assigning study specific task to study team personnel.
- Train team members on selected tasks.
- CRF/Database designing.
- Perform User Acceptance Testing.
- Edit Check Specification Preparation/Review/Programming/ Testing.
Clinical Data Coordinator
Quartesian Clinical Research Pvt.ltd
06.2012 - 05.2014
- Study status tracking.
- CRF Designing.
- Verifying Annotated CRF with source documents.
- Database Designing.
- Database Testing.
- Edit Check Specification Preparation.
- Edit Check Specification Testing.
- Query Management.
- Archiving of all study related documents.
- Participate in appropriate project meetings.
- Other duties assigned by immediate supervisor/manager.
Clinical Data Coordinator Trainee
Quartesian Clinical Research Pvt.ltd
12.2011 - 06.2012
- Study status tracking.
- Data entry.
- Verification (second entry).
- CRF creation in PageMaker based on design prepared by Data Manager/designee.
- Edit check testing.
- Creating test subjects for testing purposes.
- Archiving of all study related documents.
- Participate in appropriate project meetings.
- Other duties assigned by immediate supervisor/manager.
Education
B.Sc., Mathematics -
Palayamkottai, ST. Xavier’s College
Tirunelveli, Tamil Nadu 06.2008 - 04.2011
Higher Secondary -
Gramma Committee Higher Secondary School
Tirunelveli, Tamil Nadu 06.2006 - 04.2008
Secondary (SSLC) -
Gramma Committee Higher Secondary School
Tirunelveli, Tamil Nadu 06.2005 - 04.2006
Skills
iMedidata
Medrio
Veeva
Confero
Database Programming
Edit Check Specs Creation
User Acceptance Testing for both eCRF & ECS
SDTM mappings on eCRF
CSR Documents Review
MS-office
Adobe Page Maker
Adobe InDesign CC
Roles And Responsibilities
- Protocol Review.
- Performing Database design (eCRF).
- ECRF review to ensure in compliance with the protocol.
- Performing Database testing for eCRF screens (UAT).
- Resolving User Acceptance Testing Issues.
- Edit check specification Preparation.
- Edit check specification review.
- Edit Checks programming.
- Resolving programming Issues
- Test case preparation and Data Entry.
- Edit Check Testing. (UAT of Edit checks)
- Database Deployment
- ECCG and DMP review
- Managing Project related Documents (Including Study Archival)
- Post Production Support (Migration Process)
- Act as study POC and able to manage the deliverable on time
- SDTM Annotation (Blank CRF)
- Clinical Study Report Publishing and QC (m1, m2 and m5 Structure Submission)
- Manage the UAT activities.
Clinical Research Skills
Comprehensive understanding of all phases of clinical trials, drug development, clinical processes and regulatory affairs, Ability to understand the protocol and its components., Hands on experience of clinical data management system Medrio, Medidata Rave, Open Clinica, Alpha Clinical Systems and iMedNet., Good understanding of Data Management Plan (DMP)., Ability to prepare database structure document, edit check specification document., Good Knowledge in discrepancy and query management., Knowledge about CDISC, CDASH and its standards., Aware of data management SOP’s., Good understanding of the roles and responsibilities of study personnel in Clinical Data Management.
Medidata Rave Expertise - Modules
- Architect
- Edit Checks Programming & Derivation
- Amendment Manager
- Reporter
- Query Management
- PDF Generator
Personal Information
- Father's Name: Annamalai @ Singadurai
- Date of Birth: 02/23/91
- Gender: Male
- Nationality: Indian
- Marital Status: Unmarried
- Religion: Hindu
Medrio Expertise - Skills
- Database build and edit check programming
- Query management
- Deployment
Project Experience
- Bacterial infections, Bioequivalence
- Cardiology/Vascular Diseases, Phase I
- Central Nervous System, Phase I
- Circulatory System, Phase I
- Dermatology, Phase I, Phase II, Phase III, Phase IV, Clinical Endpoints
- Endocrinology, Non-interventional study, Pilot
- Hematology, Phase I
- Hepatology, Phase I, Bioequivalence
- Musculoskeletal, Phase III, Clinical Endpoints, Bioequivalence
- Nephrology, Phase I
- Neurology, Phase I
- Oncology, Phase I
- Ophthalmology, Phase II
- Podiatry, Phase I
- Pulmonary, Phase I
- Respiratory, Phase I, Phase II, Bioequivalence
Other Skills And Awards
Good communication and written skills along with strong technical skills, Very organized and proactive and Good team player, Self-motivated and desirable to work in a team environment., Possess excellent project management, coordination and organizational skills., Ability to act independently and with an initiative to resolving problems.
Training
- Medidata Rave Study Design and Build Essentials
- MEDRIO Electronic Data Capture and Study Build
- IMedNet Electronic Data Capture and Study Build
- Open Clinica Query Management
- Veeva Vault Electronic Data Capture and Study Build
Disclaimer
I solemnly declare that all the furnished here are true and complete to the best of my knowledge and belief.
Timeline
Assistant Manager - Clinical Data Management
VERANEX
01.2022 - 12.2022
Team Lead-Subject Matter Expert EDC
QUARTESIAN (AQUIRED BY VERANEX IN JUNE 2021)
01.2020 - 12.2021
Senior Clinical Database Programmer
Quartesian Clinical Research Pvt.ltd
01.2017 - 12.2019
Clinical Data Coordinator II
Quartesian Clinical Research Pvt.ltd
06.2014 - 12.2016
Clinical Data Coordinator
Quartesian Clinical Research Pvt.ltd
06.2012 - 05.2014
Clinical Data Coordinator Trainee
Quartesian Clinical Research Pvt.ltd
12.2011 - 06.2012
B.Sc., Mathematics -
Palayamkottai, ST. Xavier’s College
06.2008 - 04.2011
Higher Secondary -
Gramma Committee Higher Secondary School
06.2006 - 04.2008
Secondary (SSLC) -
Gramma Committee Higher Secondary School
06.2005 - 04.2006
Associate Manager - Clinical Data Management
VERANEX
1 2023 - Current