Himalayas logo
G CGC
Open to opportunities

G C

@gc0

Experienced Principal Clinical Data Manager with a focus on oncology.

United States
Message

What I'm looking for

I am looking for a role that values collaboration, innovation, and professional growth.

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

AT
Current

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.

PS

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.

WT

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.

QU

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.

NP

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.

EI

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 logoMU

Montclair State University

Bachelor of Science, Biology

2000 - 2004

Completed a Bachelor of Science in Biology. Studied various biological principles and scientific methodologies.

Tech stack

Software and tools used professionally

Interested in hiring G?

You can contact G and 90k+ other talented remote workers on Himalayas.

Message G

People also viewed

View all talent

Find your dream job

Sign up now and join over 100,000 remote workers who receive personalized job alerts, curated job matches, and more for free!

Sign up
Himalayas profile for an example user named Frankie Sullivan
G C - Principal Clinical Data Manager - Actalent Services / Moderna Therapeutics | Himalayas