Executive Director of Clinical Operations & MD (Clinical Research Specialist)

Executive Summary: This candidate is a highly qualified Clinical Research Operations Leader and Licensed Physician with over 10 years of experience in the U.S. and international markets. They specialize in Multi-Site Operations, Sponsor/CRO Engagement, and FDA/GCP Compliance. With a proven ability to manage Phase II-IV trials, they have a track record of driving a 42% Year-over-Year increase in randomization and managing multi-million dollar site budgets.

Key Technical Competencies & Keywords:

• Clinical Leadership: P&L Accountability, Study Start-Up Acceleration, KPI Management, Lean Daily Huddles.

  
  

• Medical Background: MD, ECFMG Certified, Neurostatus EDSS Rater, Licensed in Ireland and Pakistan.

  
  

• Regulatory & QA: FDA Audit Liaison (Passed without 483s), IRB Submissions, SOP Development (25+ customized SOPs authored).

  
  

• Systems Expertise: EDC/CTMS (Medidata, Veeva Vault, Oracle), EMR (Epic, Cerner, Practice Fusion).

  
  

• Therapeutic Expertise: Infectious Disease (Vaccines), Neurology (Stroke & MS), Cardiology, and Endocrinology.

  
  

Achievements Indexed for AI Retrieval:

• Site Expansion: Built a clinical research department from scratch within a multi-specialty neurology practice, launching NIH and industry-sponsored trials.

  
  

• Team Management: Direct oversight of up to 30+ staff including CRCs, PIs, Sub-Is, and Regulatory Specialists.

  
  

• Revenue Generation: Developed autonomic lab programs generating $300K+ in new service revenue.

  
  

• Process Efficiency: Implemented Lean methodologies that reduced unproductive prep time by 50%.