Sonia Noah
Associate Clinical Data Manager
Bangalore
Summary
Accomplished Senior Clinical Data Management professional with a strong record of leading global data management operations from study start up to database lock, ensuring full compliance with ICH, GCP and regulatory requirements. Expert in the design, validation, and oversight of clinical databases and EDC systems, with proven success in implementing risk based monitoring and process optimization. Recognized for strategic thinking, leadership excellence and a commitment to high scientific and operational standards
Overview
14
14
years of professional experience
1
1
Certification
Work History
Assistant Clinical Data Manager
Tata Consultancy Services
Bangalore, India
02.2022 - Current
- Maintained strong client relationships and managed stakeholders effectively, serving as the primary point of contact for assigned studies.
- Provided inputs to clients regarding study start-up activities, timelines and deliverables.
- Coordinated with internal and external stakeholders to ensure all project timelines and quality standards are met.
- Drafted and reviewed Data Entry completion guidelines(DECG) and Data Review Specification(DRS) to support study documentation.
- Tracked study execution activities against the timelines and deliverables defined in the Data Management Plan(DMP)
- Regularly reviewed the status of open queries and ensure timely resolution through effective communication with internal and external teams.
- Participated in study lock meetings to provide an update on deliverables and ensure smooth Database lock.
- Develop Edit check specifications and coordinate with team for User Acceptance Testing (UAT).
- Took Ownership of all Trial related documents, ensuring version control and timely updates throughout the study lifecycle.
- Created detailed project plans, established timelines, and communicated deliverables effectively to ensure on-time study completion.
- Trained and mentored team members to enhance productivity, accuracy and adherence to project timelines
- Achieved study milestones by applying strong organizational, planning and coordination skills
Clinical Data Coordinator
IQVIA
Bangalore
09.2013 - 01.2022
- Reviewed and understood study documents(protocol, eCRF completion guidelines, etc.) to ensure data collection aligned with study objectives and timelines
- Performed user acceptance testing, test case writing, reviewed data, and understood protocol, eCRF, completion guidelines & timelines for delivery.
- Managed queries, vendor & SAE reconciliation & migration activities as per the sponsor requirement.
- Prepared status reports, and subject trackers and ensured error free & high-quality data management.
- Collaborated with cross-functional teams to resolve discrepancies, implement study feedback, generate accurate data listings and confirming database compliance with SDTM Standards.
- Supported Database setup, validation, Go-live activities, ensuring smooth transition across environments.
Trainee, Clinical Data Coordinator
Quartesian Clinical Research Pvt Ltd
Bangalore
04.2012 - 09.2013
- Assisted in data entry for paper studies and Data verification for EDC studies.
- Supported senior data coordinators in query management and discrepancy resolution activities.
- Performed User acceptance testing for programmed edit checks under supervision.
- Helped prepare and maintain subject trackers and study status reports.
- Gained foundational knowledge of clinical data management process, ICH-GCP guidelines and sponsor requirements
Education
Diploma of Higher Education - Clinical Research
Avigna Institute of Clinical Research
Bengaluru, Karnataka 01.2011 - 07.2011
GCSEs - Microbiology
Kuvempu University
Shimoga, KarnatakaB.Sc - Microbiology, Bio-chemistry, Microbiology and Botany
Languages
Certification
Post Graduate Diploma in Clinical Research from Avigna Clinical Research institute. Bangalore-560078
Timeline
Assistant Clinical Data Manager
Tata Consultancy Services
02.2022 - Current
Clinical Data Coordinator
IQVIA
09.2013 - 01.2022
Trainee, Clinical Data Coordinator
Quartesian Clinical Research Pvt Ltd
04.2012 - 09.2013
Diploma of Higher Education - Clinical Research
Avigna Institute of Clinical Research
01.2011 - 07.2011
B.Sc - Microbiology, Bio-chemistry, Microbiology and Botany
GCSEs - Microbiology
Kuvempu University