Lourdu Naveena C
Salem
Summary
Dedicated Clinical Data Management professional seeking growth in the Clinical Research domain, aiming to contribute to quality-driven data operations and process improvements.
Overview
8
8
years of professional experience
Work History
Senior Quality Assurance Specialist I
Kur Research (Atlas essentials)
Chennai
09.2023 - 04.2025
- Oversaw data accuracy, query resolution, reconciliation, and CTMS-EDC data flow.
- Conducted quality reviews per ICH-GCP and SOP standards.
- Supported compliance tracking, staff training, and internal QA processes.
- Delivered regular updates and audit readiness reporting.
Clinical Data Coordinator II
Navitas
Chennai
09.2022 - 09.2023
- Led data discrepancy management, edit check validation, SAE/external data reconciliation.
- Prepared test documentation and mentored junior staff.
- Acted as study lead and ensured quality delivery of status reports.
Clinical Data Manager
Clinovo
Hyderabad
10.2021 - 09.2022
- Handled end-to-end data management including CRF design, DVS, UAT, and study documentation.
- Primary POC for client communications and deliverables.
Clinical Data Coordinator II
ICON PLC
Chennai
04.2021 - 07.2021
- Performed data cleaning, SAE reconciliation, and edit check validation.
- Represented DM in sponsor meetings and mentored new team members.
Clinical Data Coordinator I
ICON PLC
Chennai
08.2018 - 03.2021
- Conducted manual reviews, discrepancy management, reconciliation, and study documentation
Assistant Clinical Data Coordinator
ICON PLC
Chennai
11.2017 - 07.2018
- Assisted with query generation, edit checks, and CRF completion tracking.
Project Assistance
ICON PLC
Chennai
11.2016 - 10.2017
- Supported project managers with documentation, training coordination, and status tracking. Assists with quality control measures as directed by Project Manager.
Education
M.Sc. - Biochemistry
Muthayammal College of Arts And Science
Rasipuram05-2017
UG Degree -
Idhaya College of Arts And Science
Pondicherry05-2015
HSC -
A.E.T Higher Secondary School
Authur12.2011
SSLC -
ST. MARY S Higher Secondary School
A.N. Mangalam12.2009
Skills
- 8 years of experience in Clinical Data Management and Quality Assurance
- Proficient with EDC systems: Medidata Rave, Inform, Veeva Vault, iMednet, Clinical One, OneClinical DSG
- Therapeutic area experience: Oncology, Dermatology, Diabetes, BABE, Device and collection trails
- Expertise in full study lifecycle: from startup (eCRF, DVP, UAT) to conduct (queries, coding, reconciliation) to close-out (freezing, locking)
- Strong stakeholder coordination and onshore collaboration and Skilled in CTMS operations, Excel reporting, and metrics tracking
- Proven leadership as a Lead and Point of Contact (POC) for multiple studies
Accomplishments
- Gold medal in M.Sc., Biochemistry.
- 1st Proficiency award in M.Sc. Biochemistry.
- District, Divisional, National certificates for volleyball.
Languages
English, Tamil (Read, Write, Speak)
First Language
Personal Information
- Father's Name: Cashmir. T
- Date of Birth: 07/26/94
- Gender: Female
- Nationality: Indian
- Marital Status: Married
Disclaimer
I hereby declare that the above information is true to the best of my knowledge and belief.
Timeline
Senior Quality Assurance Specialist I
Kur Research (Atlas essentials)
09.2023 - 04.2025
Clinical Data Coordinator II
Navitas
09.2022 - 09.2023
Clinical Data Manager
Clinovo
10.2021 - 09.2022
Clinical Data Coordinator II
ICON PLC
04.2021 - 07.2021
Clinical Data Coordinator I
ICON PLC
08.2018 - 03.2021
Assistant Clinical Data Coordinator
ICON PLC
11.2017 - 07.2018
Project Assistance
ICON PLC
11.2016 - 10.2017
M.Sc. - Biochemistry
Muthayammal College of Arts And Science
UG Degree -
Idhaya College of Arts And Science
HSC -
A.E.T Higher Secondary School
SSLC -
ST. MARY S Higher Secondary School
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