Archana D
Bengaluru
Summary
Self-motivated professional to handling sensitive and confidential records while thriving in deadline-driven environments. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Data Analyst
Fortrea (Formerly Labcorp),
2023.08 - Current
- Perform all data management tasks as appropriate to include, but not to be limited to data review
and query management to ensure that quality standards (both internal and client) are achieved. - Assist with review clinical trial data in accordance with Data Management Plans, Edit Check
Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing,
incomplete data. - Generate, resolve, and track queries to address problematic data identified during data review
activities. - Interact with other project team members to support the set-up, maintenance, and closure of the
Data Management aspects of the project and attend meetings as required. - Assist or create dummy data to test edit checks and to test database screen design and
functionality. - Assist or create dummy data to test SAS reports and data listing.
- Generate study status reports as assigned.
Clinical Data Analyst
LabCorp
2021.11 - 2023.08
- Performing discrepancy management in accordance with the agreed timelines.
- Reviewing all Protocol Deviations.
- Performing vendor Reconciliations, SAE Recon.
- Executing data listings programs and dataset reviews for patient data consistency, quality and
completeness. - Perform discrepancy management on front end checks and programmed consistency checks.
- Communicate with particular site CRA’s and CTL’s for site related issues for Quality of the data.
- Preparing Metrics, CPT and Issue logs on daily basis and sending to Clint as per study requirement.
- Performed on Freezing and Locking activities.
Clinical Data Specialist
IQVIA
2018.07 - 2021.11
- Worked as Backup Study lead (Data Management) for multiple trials. This involves client facing to
ascertain requirements and managing internal and external teams for efficient and quality focused
delivery. - Performed data management tasks for Phase I-III clinical studies.
- Reconciled Serious adverse events (SAE); Lab data, Reconciled PK/PD files, vendor recon, reviewed
tables and listings ongoing basis and prior database lock. - Responsible for administrative review of the study and study assessment. Complete understanding of the tool to perform end to end process and ensure quality for assigned tasks involving internal and external deliverables.
- Preparing Metrics, CPT and Issue logs on daily basis and sending to Clint as per study requirement.
- Performed on Freezing and Locking activities.
Education
Master of Science - Biochemistry
REVA University
Bengaluru, India06.2018
Bachelor of Science - Biotechnology, Biochemistry, Genetics
REVA Institute of Science And Management,
Bengaluru, India06.2016
Skills
- EDC Systems (Medidata RAVE)
- INFORM
- eCaseLink
- IBM
- Internal applications as per the client’s requirement.
Certification
- NIDA Clinical Trials Network Certification.
- Certification on Clinical Research, Pharmacovigilance, Clinical Data Management from “CLINI INDIA” Institute.
ACHIVEMENTS:
- Appreciated twice as ‘Momentum Maker’ for diligence, client focus, Pro-activeness and
for great Team Player. - Got Special Achievement Award and various other awards like Bravo.
- Best Mentee.
Languages
English
Advanced (C1)
kannada
Bilingual or Proficient (C2)
Hindi
Intermediate (B1)
Telugu
Intermediate (B1)
Timeline
Clinical Data Analyst
Fortrea (Formerly Labcorp),
2023.08 - Current
Clinical Data Analyst
LabCorp
2021.11 - 2023.08
Clinical Data Specialist
IQVIA
2018.07 - 2021.11
Master of Science - Biochemistry
REVA University
Bachelor of Science - Biotechnology, Biochemistry, Genetics
REVA Institute of Science And Management,
- NIDA Clinical Trials Network Certification.
- Certification on Clinical Research, Pharmacovigilance, Clinical Data Management from “CLINI INDIA” Institute.
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