Kelly Doyle

About Kelly Doyle

I am an accomplished clinical research and operations professional with a proven track record of leading strategic initiatives that advance patient-centered drug development. As the Lead for Clinical Outcomes Assessments (COAs) and Licensing at Merck, I oversee the governance, licensing, and translation of COAs, clinical copyrights, scores/calculations, and rater training licenses that support global clinical research quality, compliance, and data integrity.My work bridges science, strategy, and operational execution driving alignment across Therapeutic Areas (TAs), global affiliates, and cross-functional teams to ensure consistency, innovation, and regulatory readiness.With a deep understanding of the clinical development lifecycle, I am passionate about optimizing processes, strengthening partnerships, and enabling teams to deliver meaningful outcomes for patients worldwide.Core strengths include:• Strategic leadership in COA governance and licensing• Global cross-functional collaboration and stakeholder management• Clinical operations, regulatory compliance, and quality systems• Process optimization, risk mitigation, and portfolio alignment

Experience

1. Director, Licensing and Translations Clinical Outcomes Assessments and Copyrights

   Merck

   Feb 2025 — Present

   Provides strategic leadership and oversight for the licensing, translation, and governance of Clinical Outcomes Assessments (COAs), clinical copyrights, calculations/scoring, and rater training licenses supporting Merck’s clinical research and drug development programs. Partners cross-functionally to ensure operational excellence, compliance, and consistency across all Therapeutic Areas (TAs) and indications.Drives alignment of COA and rater training strategies with global standards to enhance data quality, regulatory readiness, and patient-centric outcomes.

Education

• Marymount University

  Doctorate in Business Administration in Business Intelligence and Technology

• Chestnut Hill College

  BS in Business Admin, Business Administration

  2008

• Drexel University College of Medicine

  Masters of Science , Clinical Research Organization and Management

  2017

Skills

• Clinical Trials
• Ctms
• Gcp
• Clinical Research
• Pharmaceutical Industry
• Vaccines
• Diabetes
• CRO
• Cardiology
• Therapeutic Areas
• Clinical Development
• Oncology
• Respiratory and Immunology
• Project Management
• Clinicaltrials.gov
• Sharepoint
• Tmf
• Sop
• Protocol
• Clinical Operations
• Trial Management
• Regulatory Documentation
• Clinical Study Design
• Phase I
• Pharmacovigilance
• Ich-Gcp
• Edc
• Regulatory Submissions
• Clinical Data Management
• Clinical Monitoring
• Biotechnology
• Customer Service
• Management
• Microsoft Office
• Good Clinical Practice (Gcp)
• Clinical Trial Management System (Ctms)
• Standard Operating Procedure (Sop)
• CRO Management