Summary
Overview
Work History
Education
Skills
Therapeutic Experience
Systems and Tools
Vendor Experience
Professional Memberships
Work Preference
Timeline
Open To Work
Hi, I’m

Scott Wood

Summary

Senior Clinical Trial Leader with 15+ years of experience managing global clinical trials (Phases I–IV).

Demonstrated success accelerating critical clinical milestones, including early database locks, expedited enrollment, and first patient randomization across complex global studies. Proven ability to support FDA inspection readiness and achieve strong audit outcomes with minimal findings.

Known for strong leadership and proactive problem-solving in high-pressure environments including study rescues.

Expert in vendor oversight, risk mitigation, cross-functional leadership, and study delivery from start-up through database lock and regulatory submission support.

Overview

18
years of professional experience

Work History

ICON Clinical Research (remote)
Blue Bell, Pennsylvania

Sr. Clinical Trial Manager / Project Manager
10.2016 - 06.2025

Job overview

  • Accelerated key milestones including FPI (First Patient In), FPR (First Patient Randomized), and DBL (Database Lock), achieving select database locks 2-4 weeks ahead of plan, resulting in expedited study timelines.
  • Resolved high-risk study issues including CRA turnover (1–3 CRAs), enrollment delays, and data backlog recovery impacting 150 subjects per study, leading to improved study continuity and participant engagement.
  • Supported FDA inspection readiness, contributing to 2 successful FDA audits with minimal findings, thereby enhancing the credibility and compliance of clinical operations.
  • Managed 3–6 vendors per study (IRT, eCOA, central labs), enhancing coordination and decreasing issue resolution time by 15%, which improved overall project efficiency.
  • Led global Phase I–IV clinical trials across 1–12 countries, ensuring budget adherence and delivery of study outcomes, while mentoring junior staff and supporting training of CRAs/CTAs, which improved study execution consistency by 10 %.

Syneos Health (inVentiv / i3 Research) (remote)
Morrisville, North Carolina

PM / PM Assoc / Clin Monitor Proj Lead / Sr. CRA
05.2007 - 09.2016

Job overview

  • Managed study execution for 20–100 sites per study, ensuring compliance with GCP and protocol requirements to facilitate successful trial outcomes
  • Supported enrollment targets of ~150–350 subjects per study, implementing tracking and escalation processes to meet project timelines
  • Accelerated site activation by 1–3 weeks in select studies, enhancing overall study timelines
  • Improved SDV completion from ~5% to 80% within ~3 months after inheriting a high-priority study
  • Prevented protocol deviations by identifying incorrect subject randomizations and calling sites prior to dosing
  • Supported FDA and sponsor inspection readiness across 6 studies, ensuring audit-ready documentation
  • Progressed from CRA leadership to project management supporting 10–20 CRAs across global clinical trials

Education

University of Connecticut
Storrs, CT

Bachelor of Arts from Psychology

Skills

  • Global Clinical Trial Management
  • Study Start-Up
  • Study Execution
  • Study Closeout
  • Vendor Oversight (IRT, eCOA, Central Labs)
  • Risk Management
  • GCP / ICH E6 Compliance
  • FDA Inspection Readiness
  • eTMF
  • CTMS
  • Regulatory Submissions (IRB/EC)
  • Budget & Timeline Management
  • Stakeholder Engagement
  • Risk-based Monitoring

Therapeutic Experience

CNS: Alzheimer’s, Parkinson’s, Schizophrenia (Registration Trials), Bipolar Disorder, ADHD.

Rare Disease & Pediatrics: Osteogenesis Imperfecta, Duchenne Muscular Dystrophy, Infantile Spasms, Dravet Syndrome.

Cardiovascular & Developmental Disorders: Deep Vein Thrombosis (DVT) & Pulmonary Embolism (PE), Cerebral Palsy.

Systems and Tools

EDC: Oracle RDC, Oracle InForm, Medidata Rave
CTMS: Medidata, PROMIS, iCube, ICOTrial
eTMF: Veeva Vault, Wingspan, Documentum
Other: Smartsheet, ClinPay, Study Central, WebEx, Firecrest
Microsoft Office: Excel, Word, PowerPoint, Project

Vendor Experience

 IRT: Almac, Endpoint, Flex advantage, Sharp
Central Labs: Covance, ACM, ICON Central Lab
ECG: Clario, Cardiocore
Rater Training: Medavante, UBC, Inventiv Health

 Drug Distribution: Catalent, Almac, Sharp

 Other: Greenphire

Professional Memberships

Society of Clinical Research Associates (SOCRA)
Project Management Institute (PMI) — CAPM Certification in Progress

Work Preference

Job Search Status

Open to work

Work Type

Full TimeContract Work

Location Preference

RemoteOn-Site

Salary Range

$94000/yr - $200000/yr

Timeline

Sr. Clinical Trial Manager / Project Manager

ICON Clinical Research (remote)
10.2016 - 06.2025

PM / PM Assoc / Clin Monitor Proj Lead / Sr. CRA

Syneos Health (inVentiv / i3 Research) (remote)
05.2007 - 09.2016

University of Connecticut

Bachelor of Arts from Psychology
Scott Wood