Briana A.
Clinical Data Management Leader
- Role
- Head of Clinical Data Management at Pliant Therapeutics
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Briana A.
Member of Society for Clinical Data Management (SCDM) and Certified Clinical Data Manager (CCDM) with ~20 years of experience ensuring compliance with GCP, ICH, Agency Regulations, including 21 CFR Part 11 and ICH E6. Proficient in navigating HIPAA, GDPR, and utilizing CDISC CDASH and SDTM Standards for data quality and regulatory compliance.• Energetic, agile, and supportive leader known for strong interpersonal skills and proactive problem-solving. Achieved success in fostering team growth, achieving ambitious goals, and optimizing processes for timely, high-quality data delivery. Recognized for kind and effective communication, collaboration, and enhancing vendor relationships and data standards. • CDMS expertise in Rave EDC, RTSM/Balance, and Safety Gateway (Medidata Build and URL Admin certifications/trainings), InForm, Medrio, Oracle Clinical (RDC and paper), BioClinica, IBM, and DataFax. Familiar with coding dictionaries including WHODrug, MedDRA, and ICD-9.• Diverse therapeutic areas of experience including Oncology, Alzheimer’s Disease, Pain Management, Cardiology, Immunology, Infectious Disease, Psychology, Musculoskeletal Disease, Ophthalmology, and Medical Device studies.• Oncology Assessment Criteria knowledge includes i/RECIST, Lugano/Chesson, IMWG, PCWG, iwCLL, and RANO. Various Biomarker and Staging System experience.
Experience
Head of Clinical Data Management
Jun 2024 — Present · South San Francisco, CA, US
Education
University of California, Santa Cruz
BA, Anthropology
2003
Notre Dame de Namur University
Master of Science (MS), Management
2014
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