Kathleen McCarthy

Manager, Quality Review at Bristol Myers Squibb @ Bristol Myers Squibb

About

Clinical Documentation Quality Review Specialist with 15+ years of experience supporting pharmaceutical and life‑sciences organizations in regulated environments. I specialize in clinical document quality review, source data verification (SDV), and technical/formatting compliance for submission‑ready documentation.My background includes hands‑on review of protocols, protocol amendments, clinical study reports (CSRs), investigator brochures, informed consent forms (ICFs), and regulatory summaries, with a strong focus on accuracy, consistency, traceability, and adherence to internal and global authoring standards.I’ve partnered closely with clinical scientists, pharmacologists, pharmacometricians, regulatory affairs, QA, and submission teams—often in remote settings—to resolve quality issues efficiently and support inspection readiness. I’m known for being detail‑oriented, collaborative, and dependable under tight timelines.Areas of expertise: Clinical QC, SDV, submission support, inspection readiness, SOP/cGMP compliance, and document management systems.I’m actively seeking remote Clinical Documentation Quality Review / Clinical QC roles within pharmaceutical, biotech, CRO, or FSP environments.

Country

United States

City

Denville

Industry

Pharmaceuticals

Skill

Quality Assurance Review, Adverse Events Processing, Regulatory Affairs Associate, Documentum, ARISg, Microsoft Office 2010 (Excel, Word, PowerPointa), Pharmaceutical Industry, Quality Assurance, Clinical Trials, Change Control, LIMS, Validation, Document Management, Regulatory Submissions, Regulatory Affairs, FDA, Pharmaceutics, GMP, U.S. Food and Drug Administration (FDA), Management

Experience

Manager, Quality Review at Bristol Myers Squibb

Bristol Myers Squibb

2025-6 - Present · 1 yr 4 mos

Clinical Pharmacology QC Specialist

Bristol Myers Squibb

2021-3 - 2025-6 · 4 yrs 4 mos

Summit, New Jersey, United States

• Perform source data verification (SDV) QC utilizing sources and references in clinical documents such as protocols, protocol amendments, Summary of Changes, and Informed Consent Forms. SDV QC includes review of documents for content accuracy, completeness, and consistency against source documents. • Complete format and technical review of clinical documentations including protocols, protocol amendments, Summary of Changes, and Informed Consent Forms. • Communicate effectively with document authors including clinical scientists, pharmacologists and pharmacometricians regarding review of clinical documentation.

Document Control Manager

Novartis

2020-2 - 2021-3 · 1 yr 2 mos

East Hanover, New Jersey, United States

• Perform source data verification (SDV) on Pharmacokinetic (PK), Pharmacology and Toxicology Written Summaries, EU CTA Section 4.2.3 and Section 4.2.3.4, IND Annual Report Section 2.7.4, and Investigator Brochures • Complete NovStyle review of clinical and preclinical documentation to ensure successful health authority submissions including the following document types: Protocols and Protocol Amendments, Informed Consent Forms, Product Handling Manual, Monitoring Plan, Toxicology Letter Report, DIS reports, DMPK reports, Toxicology Written Summaries, CV and Signature page, and Investigator Brochures • Complete CREDI ‘Check’ and SubWay ‘Format Review’ states to ensure timely submission status and compliance to NovStyle guidelines • Assist with management and troubleshooting of document lifecycle issues