Archana S

Accomplished Clinical Data Management and Regulatory Affairs professional with 4+ years of progressive experience across leading global CROs and pharmaceutical service organizations (Premier Research, IQVIA, Accenture). Proven expertise in end-to-end clinical data lifecycle management — from CRF/eCRF design, database build, UAT, and query management through database lock and regulatory submission. Hands-on proficiency with Medidata Rave, Oracle Clinical, and Veeva Vault.

Experienced in eCTD/pCTD regulatory submissions, clinical document redaction, ICH-GCP compliance, and cross-functional stakeholder collaboration. Known for delivering high-quality, inspection-ready outputs under tight regulatory deadlines. Holds a Bachelor of Pharmacy and strong academic grounding in clinical research principles, biostatistics, and pharmacovigilance.

Associate Data Manager - Premier Research - Bengaluru, India

(2025-01)

Manage end-to-end data management activities for Phase II–III clinical trials, ensuring database integrity, protocol adherence, and full compliance with Data Management Plans (DMPs) and regulatory standards.

• Lead CRF/eCRF review cycles, edit check specification development, and oversee User Acceptance Testing (UAT) to validate database build accuracy and system performance prior to study go-live.
• Generate, track, and resolve data queries with internal stakeholders (Biostatistics, Clinical Operations, Medical Affairs) and external site personnel to correct data discrepancies and maintain data quality.
• Author and maintain comprehensive Data Management Plans (DMPs), testing results documentation, and follow-up testing reports ensuring audit-trail completeness and inspection readiness.
• Conduct systematic database update verification and output validation, ensuring accuracy of interim and final data listings and statistical deliverables.
• Contribute to continuous process improvement initiatives and SOP updates within the data management function to strengthen operational efficiency and regulatory compliance.

Associate Clinical Data Coordinator (FSP) — J&J - IQVIA - Bengaluru, India

(2024-11 - 2025-05)

Served as functional representative of the Data Manager across multiple concurrent clinical trials, coordinating full-scope data management activities under J&J's FSP engagement model.

• Partnered with Clinical Operations, Biostatistics, and Medical Affairs teams to ensure data accuracy, protocol compliance, and timely delivery of clean datasets for analysis and regulatory submission.
• Led CRF/eCRF design sessions, database setup activities, and edit check specification reviews in Medidata Rave (CDMS), ensuring alignment with protocol requirements and sponsor standards.
• Managed comprehensive query lifecycle — from generation through resolution — for interim analysis support, data reconciliation, and study closeout activities across multiple active studies.
• Supported full UAT cycles for clinical data management systems (Rave/CDMS), authoring and executing test scripts and documenting results to validate system readiness.
• Ensured strict adherence to ICH-E6 GCP guidelines, 21 CFR Part 11 requirements, and sponsor-specific regulatory frameworks throughout all data management activities.

Clinical Trial Disclosure & Data Management FSP - Accenture Solutions Pvt. Ltd. - Bengaluru, India

(2023-05 - 2024-07)

Managed clinical document redaction workflows across multiple concurrent clinical studies, ensuring confidentiality protection and full compliance with regulatory disclosure requirements (EMA, FDA, PMDA).

• Designed and implemented study-specific redaction strategies, defining scope, methodology, and quality standards for clinical study reports (CSRs), protocols, and associated regulatory documents.
• Performed rigorous quality control (QC) reviews against submission readiness checklists, ensuring documents met regulatory authority standards prior to dossier submission.
• Tracked study-level workloads, milestones, and timelines using project tracking tools, consistently meeting regulatory submission deadlines across high-volume portfolios.
• Collaborated with cross-functional teams including Legal, Clinical Operations, and Regulatory Affairs to identify and resolve complex documentation issues, ambiguities, and classification disputes.

Regulatory Services Associate - Alchemy Techsol (Accenture Solutions Pvt. Ltd.) - Bengaluru, India

(2021-12 - 2023-03)

Executed end-to-end eCTD (Electronic Common Technical Document) and pCTD submissions to global health authorities, ensuring sequence integrity, technical validation, and on-time delivery.

• Performed peer review quality checks on regulatory documents and managed archival, version control, and lifecycle management using Veeva Vault content management system.
• Assisted in preparation, compilation, and submission of IND, NDA, MAA, and variation dossiers to regulatory authorities including FDA, EMA, and CDSCO.
• Monitored regulatory compliance across active submissions, coordinating with internal stakeholders and health authority liaison teams to resolve technical inquiries and deficiency letters.
• Supported internal regulatory audits and inspection readiness activities, maintaining submission archives and regulatory tracking logs in compliance with SOPs and quality standards.

Class Teacher & Subject Teacher - Christ The King English School - Bengaluru, India

(2019-08 - 2021-12)

Delivered structured curriculum in Social Studies and Science across multiple grade levels, developing lesson plans that promoted analytical thinking, scientific reasoning, and student engagement.

• Maintained detailed academic records, monitored student performance metrics, and coordinated with parents and school administration on academic progress and student welfare.

Bachelor of Pharmacy - Pharmacy - Aditya College of Pharmacy (2019)