Azhar Bisle, MSM-HCA, CSM's Resume

Azhar Bisle, MSM-HCA, CSM

Associate Director, Quality & Compliance, GCP Lead@Cabaletta Bio | Founder@BISLE Consulting Firm, LLC

Nationality

Summary

Clinical Compliance & Quality | Ensuring GCP Compliance & Clinical System Adoptions | TMF Expert. With over 15 years of experience in clinical research, I am a passionate and ethical Clinical Compliance & Quality professional, with recently having completed a merger & acquisition with Pfizer, one of the world's leading biopharmaceutical companies. My mission is to ensure the highest standards of quality and compliance for all clinical trials conducted by any company, client, from site level to sponsor level. Bringing life changing medicine to patients is my north star. I have extensive expertise in Good Clinical Practice (GCP) training, electronic Trial Master File (eTMF), EDC, CTMS implementations and maintenance through Standard Operating Procedures (SOPs) development and review, quality assurance, internal audits, and inspection readiness. I collaborate with R&D trial teams, quality assurance, and vendors to establish and manage trial-specific training curriculums, compliance escalations, governing documents, and clinical systems. I also provide support and guidance on global regulatory requirements, client-vendor evaluation, and FDA/EMA inspections and approval. I am always looking for opportunities to improve processes, enhance efficiency, and foster a culture of compliance and excellence. It is my honor to work in this field, saving lives.

Work experience

Associate Director, Quality & Compliance, GCP Lead
Cabaletta Bio
2026.02-Current
(6 months)
Founder
BISLE Consulting Firm, LLC
2019.10-Current
(7 years)
Senior Manager, Clinical Compliance
Moderna
2023.09-2025.09
(2 years)
Clinical Compliance Manager
Pfizer
2022.03-2023.03
(a year)
Clinical Compliance Manager
Arena Pharmaceuticals, Inc.
2021.03-2022.03
(a year)
Clinical Operations Consultant (TMF Expert)/Trial Administrator
Various Companies
2019.10-2021.01
(a year)
Clinical Advisor
National Institute of Allergy and Infectious Diseases (NIAID)
2019.01-2019.09
(9 months)
Clinical Trial Management/Administration
Esperion - The Lipid Management Company
2018.05-2018.11
(7 months)
Clinical Document Management Specialist
MedImmune
2017.06-2018.04
(a year)
Clinical Operations Document Management Specialist
PRA Health Sciences
2016.12-2017.05
(6 months)
Clinical Research Coordinator
ThreeWire, Inc.
2016.03-2016.07
(5 months)
Case Advocate
Medical Technology Partners
2015.12-2016.03
(4 months)
Case Manager Consultant
AmerisourceBergen
2015.04-2015.10
(7 months)
Senior Reimbursement Consultant
AmerisourceBergen
2015.02-2015.10
(9 months)
Benefits Verification Specialist
AmerisourceBergen
2014.10-2015.01
(4 months)
Research Assistant
Towson University
2012.08-2014.01
(a year)
Event Assistant
Montgomery College
2009.11-2013.01
(3 years)

Educational experience

University of Maryland Global Campus
Master of Science - MS, Health/Health Care Administration/Management
2015.01-2017.01
(2 years)
Towson University
Bachelor's Degree, Psychology, Gerontology
2012.01-2013.01
(a year)
Montgomery College
Associate's Degree, Physical Sciences
2008.01-2011.01
(3 years)