Helen Oduselu
@helenoduselu
Clinical Trial Manager driving global Phase I–IV programs with inspection-ready execution and timeline acceleration.
United StatesWhat I'm looking for
I am a clinical trial leader with 9+ years managing global Phase I–IV studies across rare disease, vaccine, infectious disease, and cardio-metabolic programs. I have led multimillion-dollar studies, directed CRO and vendor operations, and delivered inspection-ready TMF strategies while surpassing enrollment, timeline, and budget targets.
I specialize in trial turnarounds, timeline acceleration, and regulatory engagement (FDA, EMA), and I consistently reduce delays and mitigate risk through proactive monitoring, cross-functional leadership, and robust reporting. My achievements include restoring data flow in high-urgency programs, eliminating TMF gaps ahead of closeout, and driving 100% SDV compliance with zero audit findings.
Experience
Work history, roles, and key accomplishments
Clinical Trial Manager
Prothena Biosciences
Aug 2023 - Aug 2024 (1 year)
Led global Phase II rare disease trial execution, managing TMF (Veeva Vault), budgets, CROs and vendors to maintain inspection-ready documentation and meet enrollment and timeline targets.
MTOrchestrated global Phase II vaccine and infectious disease trials with 250+ participants, improving milestone visibility with Smartsheet and resolving cross-vendor issues to accelerate database lock readiness.
PPClinical Team Manager
PPD
Jul 2020 - Dec 2021 (1 year 5 months)
Directed CRA team for Phase III cardio-metabolic trials across 15+ US sites, achieving 100% SDV compliance, zero audit findings, eliminating a 35% query backlog and ensuring TMF inspection readiness.
SHClinical Operations Lead
Syneos Health
Nov 2018 - Apr 2020 (1 year 5 months)
Led global site operations and risk-based monitoring, reducing protocol deviation reporting time by 40% and managing protocol amendment rollouts with no compliance lapses.
SHClinical Research Associate
Syneos Health
Aug 2015 - Nov 2018 (3 years 3 months)
Monitored 15+ sites for Phase III infectious disease and oncology programs, ensuring GCP compliance, drug accountability and resolution of 200+ site-level issues.
CAQuality Control Specialist
Children's Healthcare of Atlanta
Jul 2010 - Jul 2015 (5 years)
Executed QA initiatives pre-EHR launch, improving workflows and supporting audits to strengthen clinical systems and compliance.
Education
Degrees, certifications, and relevant coursework
DMDeVry University Keller Graduate School of Management
Master of Business Administration, Project Management
Completed an MBA with a focus on project management to support leadership in clinical operations and trial program delivery.
CUClayton State University
Bachelor of Science, Healthcare Management
Earned a Bachelor of Science in Healthcare Management providing foundational knowledge in healthcare systems and administration.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
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