PALAK NIGAM
Fuquay-Varina,NC
Summary
Specializing in Oncology & Cardiovascular Trials | Data Quality & Compliance Expert
Detail-oriented Clinical Data Management professional with around 5 years of experience in global clinical research. Proven success in managing the full lifecycle of data operations across Phase I–III trials. Skilled in eCRF design, UAT, discrepancy management, and vendor oversight. Adept in CDISC, SDTM, and GCP compliance. Recognized for enhancing data quality, driving cross-functional collaboration, and accelerating study timelines.
Overview
6
6
years of professional experience
1
1
Certification
Work History
SENIOR CLINICAL DATA MANAGER
GE Healthcare
01.2024 - 09.2024
- Managed the clinical data management process for 15+ clinical trials, ensuring 100% data accuracy and timeliness. Led end-to-end clinical data management for global oncology trials, including database build, eCRF design, edit check development, and UAT.
- Oversaw query management, SAE/lab reconciliation, and data quality review across cross-functional teams.
- Ensured CDISC compliance, supported data lock readiness, and collaborated with regulatory and biostatistics teams.
- Supervised creating and validating of 200+ electronic case report forms (eCRs), reducing data entry errors by 32%.
- Initiated data cleaning procedures that reduced discrepancies by 42% and improved overall data quality.
- Utilized Medidata Rave and Oracle Inform to facilitate data capture, entry
- Implemented global SOPs for cardiovascular Phase III trials, improving consistency across CRO teams.
Clinical Data Analyst
Numpy Ninja
07.2023 - 12.2023
- Extracted and cleaned clinical trial datasets (EMR/EHR) using SQL for downstream analytics.
- Developed Tableau dashboards to visualize clinical KPIs and data trends across studies.
- Automated data pipelines using SQL to streamline ingestion from diverse systems.
- Delivered interactive dashboards that cut reporting lag by 30%.
FSP PRINCIPAL CLINICAL DATA MANAGER
Arrowhead Pharmaceutical
06.2022 - 07.2023
- Implemented Medidata Rave EDC system for a global Phase III trial, reducing data entry errors by 50% and enabling real-time data monitoring. Implemented comprehensive data management quality system that reduced data discrepancies by 40% across clinical trials, ensuring high standards of accuracy and reliability .
- Streamlined data cleaning processes by introducing automated validation checks, which cut the data verification timeline by 30%, speeding up trial timelines.
- Developed and implemented data management plans aligned with GCP and 21 CFR Part 11 requirements for 8 studies
- Led database builds in Medidata Rave, ensuring CDASH and SDTM alignment.
- Implemented Medidata Rave EDC system for a global Phase III trial, reducing data entry errors by 50% and enabling real-time data monitoring.
CLINICAL DATA MANAGER
LabCorp Drug Development
05.2021 - 05.2022
- Collaborated with cross-functional teams to ensure adherence to HIPAA and ICH guidelines, maintaining 100% compliance across all projects
- Conducted edit check programming, query generation/resolution, and UAT.
- Led migration of 2+ studies to a new EDC system, completing all migrations ahead of schedule
- Expertise in cardiovascular clinical trials, successfully managed data for 1 Phase II studies and 1 Phase III study
- Managed clinical data for 3 oncology trials, including a pivotal Phase III study with 800+ participants
- Developed and executed data cleaning processes for a global clinical trial, resolving 600+ data queries within tight timelines
CLINICAL DATA ASSOCIATE TR.
Cytel
01.2020 - 04.2021
- Streamlined with query management, CRF tracking, and discrepancy resolution.
- Contributed to lab data reconciliation and review meetings.
- Participated in UAT and ensured GCP adherence.
- Collaborated with cross-functional teams on EDC operations.
- Resolved data queries, and ensured site adherence to protocol benchmarks.
- Supported trial monitoring activities and back-end reporting.
DENTAL PRACTITIONER
K.D.Dental hospital
12.2018 - 07.2019
- Managed full-spectrum patient care, from diagnosis to complex oral procedures.
- Upheld high standards of hygiene and operational efficiency in daily clinical practice.
Education
Master of Health Administration -
Valparaiso University
Valparaiso, Indiana05.2021
Bachelor of Dental Surgery -
Modern Dental College And Research Center
03.2018
Skills
- Clinical Data Management: eCRF Design, SAE /lab Reconciliation, UAT, QC, Discrepancy Management, Data Archival, CRO/Vendor Oversight,CDASH, SDTM, MedDRA Coding, Data Validation, DB design
- Technical tools: MEDIDATA, Veeva Vault, Oracle Clinical, J Review, Microsoft Office, SQL,Base SAS, Tableau, Python (Pandas), Power BI, QlikView, MS Project, Visio, Excel (advanced)
- Process & Compliance: SOP Development, GCP/GLP, EMR/EHR Integration, HIPAA/HITECH, Agile Framework
- Soft Skills: Team Leadership, Project Planning, Training & Mentorship, Stakeholder Communication
- Therapeutic Areas: Oncology (Solid Tumors: Prostate, Renal), Cardiovascular, Respiratory, GI, CNS, Hematology
Certification
- Google Data Analytics
- GCP / HIPAA / HITECH Training
Additional Information
- U.S. Work Authorization: Yes (H4 EAD)
- Open to: Remote / Hybrid CDM Roles across U.S.
- Career Break: Planned leave (Oct 2024 – Jul 2025)
Languages
English
Hindi
Punjabi
Timeline
SENIOR CLINICAL DATA MANAGER
GE Healthcare
01.2024 - 09.2024
Clinical Data Analyst
Numpy Ninja
07.2023 - 12.2023
FSP PRINCIPAL CLINICAL DATA MANAGER
Arrowhead Pharmaceutical
06.2022 - 07.2023
CLINICAL DATA MANAGER
LabCorp Drug Development
05.2021 - 05.2022
CLINICAL DATA ASSOCIATE TR.
Cytel
01.2020 - 04.2021
DENTAL PRACTITIONER
K.D.Dental hospital
12.2018 - 07.2019
Master of Health Administration -
Valparaiso University
Bachelor of Dental Surgery -
Modern Dental College And Research Center
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