Sonali Dsouza
Dubai, UAE
Summary
Quality assurance professional with keen eye for detail and commitment to ensuring software excellence. Adept at developing and executing test plans to identify defects and improve product quality. Known for collaborative work style and flexibility in dynamic, fast-paced environments, ensuring team success and project completion.
Overview
9
9
years of professional experience
6
6
years of post-secondary education
Work History
Clinical Validation - QA Analyst III
Anju Software Inc.
Bengaluru
04.2020 - Current
- Validation of IRMS products (Medical Infomation solution)
- Validation of CTMS Master (eClinical Product)
- Validation of Trial Master (eClinical Product)
- Ensured the quality of EDC systems (TrialMaster 5.0 & 4.2) for pharmaceutical industries.
- Conducted CRF testing, UAT, edit checks validation, and study build archive testing.
- Reviewed Case Report Forms and performed defect tracking using HP ALM/Quality Center.
- Designed and implemented user acceptance testing cases and plans.
- Provided regular updates to teams and attended scrum calls to track progress.
- Developed training materials for new team members.
- Validated clinical trial management systems.
- Collaborated with cross-functional teams to ensure seamless integration of new features and bug fixes.
Client Services Assistant I
Icon Central Laboratories
Bengaluru
07.2019 - 04.2020
- Company Overview: Icon Clinical research, Bangalore
- Data entry and quality control review into all systems for all new and updated investigator site listing for new and ongoing studies
- Queue and process all hard and soft copy lab reports
- Review and monitoring of error logs for all modes of lab report creation and delivery (fax, email, and hard copy) troubleshoot, correct and re queue as needed for the successful delivery of lab report to sites CRA’s and sponsors and liaise with the site services
- Maintain CS support database along with all other documentation of request mails and memo’s
- Collaborated closely with team members to develop tailored solutions for each client''s unique requirements.
- Assisted in conducting quality assurance assessments that helped maintain consistently high standards of service and client satisfaction.
- Coordinated with operations staff to resolve service problems and boost client satisfaction.
Clinical Research Coordinator
SYNCORP Clinical Research
Bengaluru
10.2018 - 07.2019
- Managed clinical trials while adhering to research SOPs and Good Clinical Practices.
- Coordinated patient visits, administered questionnaires, and maintained regulatory documents.
- Documented and reported adverse events accurately.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Gathered, processed, and shipped lab specimens.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
Scientific Analyst
Molecular Connections Pvt. Ltd.
Bengaluru
01.2016 - 09.2018
- Screen and analyze published research in life sciences and use it to build scientific databases.
- Literature mining/Indexing of relevant facts/key terms from scientific research articles, prognosis, protocol, meta-analysis, pre-clinical/clinical trial-based articles from the field of biology.
- Provided comprehensive key terms such as drugs, genes, enzymes, molecular pathways, medical terminologies etc
- Scientific data collection from areas like pharmacology, immunology, pharmaceuticals, bio methods, radiation technology, pre-clinical and clinical research
- Associated with a food compliance database consisting of curated repository of national and international food safety standards and regulations (USFDA, EU, CODEX, Health Canada, FSSAI) followed by data validation run using pre-coded Mongo DB
- Performed all QA process to ensure data quality, provided training and work direction to juniors.
Education
PG Diploma - Clinical Research & CDM
Syncorp Clincare Technologies (P) Ltd
Bangalore 10.2018 - 07.2019
MSc - Applied Science
St Aloysius College (Autonomous)
Mangalore 06.2013 - 05.2015
BSc - Biotechnology
St Aloysius College (Autonomous)
Mangalore 06.2010 - 05.2013
Skills
Disclaimer
I Sonali Renita D’Souza, hereby declare that the above information is true to the best of my knowledge and belief., 2nd April 2025, Dubai UAE.
Timeline
Clinical Validation - QA Analyst III
Anju Software Inc.
04.2020 - Current
Client Services Assistant I
Icon Central Laboratories
07.2019 - 04.2020
Clinical Research Coordinator
SYNCORP Clinical Research
10.2018 - 07.2019
PG Diploma - Clinical Research & CDM
Syncorp Clincare Technologies (P) Ltd
10.2018 - 07.2019
Scientific Analyst
Molecular Connections Pvt. Ltd.
01.2016 - 09.2018
MSc - Applied Science
St Aloysius College (Autonomous)
06.2013 - 05.2015
BSc - Biotechnology
St Aloysius College (Autonomous)
06.2010 - 05.2013
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