G C
@gc0
Experienced Principal Clinical Data Manager with a focus on oncology.
What I'm looking for
I am a Principal Clinical Data Manager with over 20 years of progressive experience in data management across all phases of clinical trials, specializing in oncology. My expertise lies in leading global teams, managing vendors, and ensuring high-quality data deliverables. I have a proven track record of compliance with ICH-GCP and regulatory standards, and I am adept in CRF design, UAT, eDiary testing, and data reconciliation.
Throughout my career, I have successfully managed data management activities for large, late-phase trials, authored key documentation, and conducted trend analysis. My experience includes overseeing CROs, leading cross-functional data reviews, and mentoring team members. I pride myself on my ability to deliver high-quality results on time, ensuring compliance with all necessary standards while fostering a collaborative team environment.
Experience
Work history, roles, and key accomplishments
Principal Clinical Data Manager
Actalent Services / Moderna Therapeutics
Oct 2021 - Present (3 years 10 months)
Oversaw data management activities for large, late-phase trials and managed CROs to ensure adherence to timelines, quality, and deliverables. Authored and reviewed key documentation such as CRF, DMP, CRF Completion Guidelines, DVS, and DTS.
Lead Data Manager
PRA Health Sciences
Oct 2018 - Oct 2021 (3 years)
Led clinical data coordination and cleaning activities across multiple studies, reviewing clinical/external data, reconciling discrepancies, and managing queries. Supported edit check creation, UAT, and CRF design, while mentoring team members and contributing to internal training initiatives.
Clinical Data Manager
Worldwide Clinical Trials
Feb 2017 - Oct 2018 (1 year 8 months)
Authored DMPs, CRFs, edit checks, and data review plans, leading data cleaning and reconciliation efforts to ensure vendor data alignment with DTAs. Presented in study meetings, implemented process improvements, and ensured compliance with GCP, SOPs, and quality standards.
Data Team Lead, Oncology
Quintiles
Mar 2012 - Jan 2017 (4 years 10 months)
Led end-to-end data management activities, including eCRF design and UAT, and oversaw query and coding teams, ensuring compliance with WHODrug and MedDRA. Served as a client liaison, conducted protocol/budget reviews, chaired meetings, and delivered high-quality results on-time in oncology trials.
Clinical Data Manager, Oncology
Novartis Pharmaceuticals
Nov 2006 - Jun 2011 (4 years 7 months)
Oversaw CROs to ensure quality database setup and timely delivery, managing SAE and external data reconciliation. Participated in DMP, budget, and contract reviews, and led CRF design, issue resolution, and study-level DM strategy.
Project Manager
eResearchTechnology, Inc.
Aug 2004 - Nov 2006 (2 years 3 months)
Managed the full lifecycle of clinical projects from startup to closeout, maintaining study documentation, performing QC, and conducting client presentations. Oversaw budgets, timelines, and internal/external communications, while developing training materials and participating in archiving and international studies.
Education
Degrees, certifications, and relevant coursework
Montclair State University
Bachelor of Science, Biology
2000 - 2004
Completed a Bachelor of Science in Biology. Studied various biological principles and scientific methodologies.
Availability
Location
Authorized to work in
Job categories
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