Nimmi Alex

PharmD-qualified Clinical Research and Clinical Data Management professional with 6 years of pharmaceutical clinical research experience supporting Phase I–IV clinical trials across global study teams and multiple therapeutic areas. Experienced in clinical data management, participant-facing research activities, clinical documentation, EDC systems, data review, query management, medical coding, SAE reconciliation, UAT, database lock, and study close-out. Currently gaining Canadian site-level experience as a Volunteer Clinical Research Coordinator supporting study visits, documentation, and clinical data activities.

Strong knowledge of ICH-GCP, TCPS 2, CDM SOPs, clinical trial processes, and data quality requirements, with strong attention to detail, communication, and cross-functional collaboration.

Clinical Research Coordinator - Volunteer at AMNDX Inc. (2026-08 – Present)

• Supported participant recruitment, screening, scheduling, informed consent, and study visits.
• Maintained accurate source documents, regulatory files, and participant records in accordance with ICH-GCP and study protocols.
• Assisted with clinical data entry, data review, query management, and EDC/database activities.
• Coordinated with investigators, research staff, participants, and study teams to support study operations.

Clinical Data Coder (Lead Support Clinical Data Management) at IQVIA (2021-10 – 2025-02)

Supported end-to-end clinical data management activities for Phase I–IV clinical trials, working within global, cross-functional study teams to deliver high-quality clinical data in accordance with study timelines, DMP requirements, SOPs, and ICH-GCP.

• Contributed to CRF review, Data Management Plan activities, EDC setup, data validation, data review, query management, coding, reconciliation, UAT, database lock, and study close-out.
• Performed comprehensive review of clinical data to identify inconsistencies, missing data, protocol-related issues, and potential data quality concerns, coordinating timely resolution with relevant study stakeholders.
• Managed data queries and supported SAE reconciliation, collaborating with clinical, safety, and data management teams to resolve discrepancies.
• Performed medical coding using MedDRA and WHO Drug Dictionary, ensuring accurate and consistent coding of adverse events, medical history, concomitant medications, and other clinical data.
• Participated in UAT, system validation, data review, and QC activities to ensure clinical databases and deliverables met quality requirements.
• Participated in EDC validation, UAT, and testing activities using Medidata Rave, Oracle Clinical/RDC, InForm, and other clinical data management platforms.
• Collaborated with Data Managers, Clinical Operations, Medical, Safety, Statistical Programming and other cross-functional teams to resolve complex data issues and support study milestones.
• Maintained clinical trial and TMF documentation and supported audit/inspection readiness activities.
• Contributed to process improvement initiatives by identifying opportunities to improve data review, query management, reconciliation, and study execution processes.
• Worked across multiple therapeutic areas including respiratory, diabetes, rheumatology, cardiovascular, infectious diseases, oncology, dermatology, psychiatry, and ophthalmology.
• Mentored and trained junior team members on query management, data review, coding processes, and system navigation to promote consistent data management practices.

Associate Clinical Data Coder at IQVIA (2020-04 – 2021-09)

• Supported global clinical trials through clinical data review, reconciliation, and query management activities.
• Performed SAE reconciliation, medical coding using MedDRA and WHO Drug Dictionary, and data cleaning activities to support accurate and complete clinical datasets.
• Supported dictionary upgrades, coding reconciliation, and quality-control activities.
• Maintained awareness of ICH-GCP principles, patient safety, protocol compliance, data integrity and confidentiality throughout clinical trial activities.

Clinical Data Coder Trainee at IQVIA (2019-04 – 2020-03)

• Assisted in medical coding, SAE reconciliation, and query resolution under senior supervision.
• Conducted QC checks and supported system validations.
• Assisted with documentation reviews and UAT activities.

Clinical Pharmacist Intern at Mandya Institute of Medical Sciences (2017-08 – 2018-08)

• Assisted in the preparation and organization of submissions to the Institutional Ethics Committee (IEC), including protocol documents, informed consent forms, amendments, and continuing review documentation.
• Performed patient screening activities by reviewing eligibility criteria and medical records for research.
• Supported the informed consent process by preparing study documents, coordinating participant visits, and ensuring required documentation was complete.
• Participated in clinical rounds, medication reconciliation, patient counseling, and pharmacotherapy review.
• Academic Project done on Prescribing Pattern of Non-Steroidal Anti-inflammatory Drugs in inpatients of Orthopedics department in a tertiary care hospital.

Doctor of Pharmacy in Pharmacy – Rajiv Gandhi University of Health Sciences (2012-09 – 2018-08)