Ananthu Anil
Kollam, Kerala
Summary
Clinical Study Build Programmer with over 3.8 years of experience in study build, and study maintenance. Proven experience in leading team to deliver high-quality deliverables that meet study requirements. Seeking a challenging opportunity that allows to leverage my expertise while fostering professional growth.
Overview
4
4
years of professional experience
Work History
Project Lead – Clinical Study Design
Zifo Scientific Informatics Services
Chennai
04.2025 - Current
- Led team of four technical specialists managing Post-Production Changes (PPC) in studies built in Viedoc EDC.
- Managed over 30 Change Requests as project lead, achieving timely delivery and budget compliance.
- Drafted project timelines, estimations, and resource allocations; reviewed client billing for accuracy and timely invoicing.
- Identified project dependencies, assessed risks, and developed mitigation plans to address issues.
- Attend sponsor calls as a Subject Matter Expert (SME) on study build/change request implementation.
- Validated study specifications, eCRF, edit checks, system configuration, and additional modules.
- Guide career development of direct reportees through Professional Development Plans (PDPs) and supported continuous learning within the team.
- Served as the primary coordinator for eCRF Library maintenance.
Data Manager
Zifo Scientific Informatics Services
Chennai
11.2022 - 03.2025
- Developed and maintained databases in Viedoc EDC for approximately 35 clinical studies, implemented around 30 protocol amendments, and over 100 post-production change requests.
- Led project management activities in accordance with SOPs, overseeing the design and validation of study build activities for Phase I to IV studies across diverse therapeutic areas.
- Facilitated project meetings, maintained timelines, ensured process adherence, and supported audits.
- Trained new hires on CDISC standards, study setup activities, and change request implementation. Mentored change request team members and drove performance improvements.
- Conducted User Acceptance Testing (UAT), identified errors, and facilitated CAPA meetings to enhance work quality as the primary designer/tester.
- Contributed to Standard eCRF library upkeep. Assisted with the creation of internal process documents.
Associate Analyst
Zifo Scientific Informatics Services
Chennai
11.2021 - 10.2022
- Interpret the study protocol, understand customer requirements, translate them into study specifications, and configure them on EDC.
- Develop CRFs, Study Schedule, program Dynamics and Edit Checks According to Specifications. Draft the Data Validation Specification, write test scripts, and validate edit checks.
- Configuration of special scopes such as Data Mapping, Local Lab Module, Randomization, Drug Allocation, ePRO, Language Translations, and Custom Reports.
- Implement post-production changes after performing a thorough impact analysis and risk assessment of the proposed changes.
Education
Bachelor of Science - Physics
SN College
Kollam, Kerala03-2020
Core Competencies
Skills: Clinical Database Development, EDC Validation, Project Management, Client Communication, Leadership
Clinical Systems (EDC): Viedoc, Medidata Rave, Medrio
Therapeutic Areas: Oncology, Neurology, Endocrine, Gastrointestinal, Musculoskeletal, Vaccines, Pediatrics/Neonatology, Cardiovascular, Gastroenterology, Nephrology, Respiratory, Medical Devices
Standards, Models and Terminologies: CDASH, SDTM, RECIST, iRECIST, itRECIST, PERCIST
Programming Language(s): JavaScript
Regulations: FDA, 21 CFR Part 11, EU Annex 11, GDPR, GCP, GLP, GMP, ISO 9001
Other Skills: Microsoft Excel, Microsoft Outlook, Microsoft Word, Microsoft PowerPoint
Timeline
Project Lead – Clinical Study Design
Zifo Scientific Informatics Services
04.2025 - Current
Data Manager
Zifo Scientific Informatics Services
11.2022 - 03.2025
Associate Analyst
Zifo Scientific Informatics Services
11.2021 - 10.2022
Bachelor of Science - Physics
SN College
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