Clinical Solutions & Business Development Leader in eCOA/DCT

Michael J. O’Grady

Shelton, CT *************@**.*** 412-***-****

SUMMARY

Clinical Solutions & Business Development professional with deep experience in clinical technology, drug development, and operations. Skilled in delivering innovative solutions to accelerate drug development, enhance patient engagement, and ensure compliance. Expertise in eCOA, DCT, and eConsent with PMP certification.

KEY SKILLS

Partner Adoption Sales Engineering eCOA (Electronic Clinical Outcome Assessment) Decentralized Clinical Trials (DCT) Clinical Solutions Business Development Training & Education Protocol Review Regulatory Compliance Vendor Qualification Risk Management Project Leadership

PROFESSIONAL EXPERIENCE

MDGroup – Sr. Clinical Solutions Consultant Mar 2025 – Sep 2025

Partner with pharmaceutical, biotech, and CRO clients to design and implement technology-enabled trial solutions, improving patient engagement and operational efficiency.

Translate complex protocol requirements into tailored eClinical strategies (site payments, patient stipends, DCT, and home health solutions).

Deliver consultative support across study lifecycles, including vendor qualification, risk assessment, and system integration, accelerating study start-up and reducing site burden.

Professional Consulting LLC – Founder / Consultant Oct 2023 – Mar 2025

Provided vendor management consultation for sponsor and CRO customers.

Designed study and eClinical solutions, overseeing implementation and execution.

Supported clients with technology evaluation, vendor qualification, and protocol alignment.

Medidata / Dassault Systèmes – Partner Adoption Executive 2021 – Aug 2023

Coordinated across sales, services, and development teams to foster adoption of partner-procured solutions.

Reestablished communication channels with inactive clients, securing contract renewals.

Acted as eCOA subject matter expert; trained sales specialists and guided product development.

IQVIA – Sr. Sales Engineer 2018 – Nov 2021

Educated sponsors on IQVIA’s eCOA solutions during bid defense and capabilities meetings.

Reviewed clinical protocols and supported proposal teams for eCOA solutions.

Collaborated with DCT teams on integrated proposals and represented IQVIA at C-Path initiatives.

Bracket Global – Director, Outcome Science 2016 – 2018

Conducted ePRO scientific reviews of protocols and trained sales teams on eCOA requirements.

Represented Bracket at ISPOR and C-Path industry forums as subject matter expert.

ERT / Invivodata – Sr. Clinical Ops Solution Advisor / Sales Engineer 2006 – 2015

Managed Clinical Solutions Group staff and activities, ensuring regulatory compliance and efficiency.

Delivered e-clinical solutions demonstrations with a 70% project close rate.

Developed employee training programs and monitored studies from design to data lock.

Bayer Healthcare – Sr. Clinical Systems Analyst & Programmer Analyst 1995 – 2006

Led vendor selection for global ePRO and managed IT budget across North America.

Designed and developed IVRS and EDC systems; supported transition to Medidata Rave.

EDUCATION & CERTIFICATIONS

MBA, Pharmaceutical Studies – Albertus Magnus University (Bayer Sponsored)

BA, History – The Catholic University of America

Certifications: PMP (PMI), IBM Generative AI (Applications & Prompt Engineering), HCRI Talent Acquisition

PUBLICATIONS

Co-authored multiple peer-reviewed publications in cardiology and clinical research, including works in Circulation, American Heart Journal, and JACC, plus numerous abstracts presented at ISPOR and C-Path conferences.

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