Open to opportunities

Judith Udeke

@judithudeke

Message

Dynamic Clinical Trial Manager with 16 years of international experience.

United States

Message

What I'm looking for

I am looking for a role that fosters collaboration and innovation, with opportunities for leadership and strategic impact.

I am a dynamic and innovative Clinical Trial Manager with over 16 years of international experience in driving clinical research initiatives within fast-paced environments. My expertise encompasses overseeing the complete clinical trial lifecycle—from strategic planning and protocol development to execution and regulatory compliance. I excel at uniting cross-functional teams, managing vendor relationships, and fostering collaborative partnerships to streamline operations and exceed project goals.

Throughout my career, I have implemented risk-based monitoring strategies that reduced site deviations by 30% and improved overall trial data integrity. My leadership has been instrumental in optimizing patient recruitment strategies, resulting in significant improvements in enrollment and retention. I am passionate about continuous improvement and operational excellence, and I thrive on transforming challenges into strategic opportunities for success.

Experience

Work history, roles, and key accomplishments

Current

Senior Clinical Trial Manager

Current

Centene Healthcare

Oct 2022 - Present (2 years 8 months)

Dynamic Clinical Trial Manager with expertise in overseeing the complete clinical trial lifecycle. Implemented risk-based monitoring strategies, reducing site deviations by 30% and improving trial data integrity. Managed vendor relationships and ensured compliance with regulatory bodies.

Clinical Site Management Risk Based Monitoring Vendor Management Regulatory Compliance Cross Functional Team Leadership Data Management FDA Compliance ICH GCP

Senior Clinical Trial Manager

ICON Clinical Research Service

Mar 2021 - Oct 2022 (1 year 7 months)

Led the planning, execution, and closeout of clinical trials across multiple therapeutic areas. Managed cross-functional teams and ensured compliance with regulatory requirements, achieving timely communication and resolution of issues.

Team Leadership Regulatory Compliance Budget Management Risk Assessment Vendor Management Communication Skills ICH GCP Project Coordination

Clinical Research Manager

Synteract as Syneos Health

Feb 2019 - Mar 2021 (2 years 1 month)

Managed and coordinated clinical trials, ensuring adherence to timelines and budgets. Led and mentored clinical research associates, achieving a 100% audit success rate during inspections.

Mentoring Regulatory Compliance Budget Management Risk Assessment Project Management

Clinical Team Lead

Covance USA

Jan 2016 - Feb 2019 (3 years 1 month)

Led cross-functional clinical teams for multiple Phase I-IV clinical trials. Ensured compliance with GCP and ICH guidelines, achieving zero regulatory non-compliance issues during audits.

Team Leadership GCP Risk Management Client Communication Project Coordination Budget Management Process Improvement

Senior Clinical Research Associate

Chiltern USA

Apr 2014 - Jan 2016 (1 year 9 months)

Managed clinical trial activities ensuring adherence to timelines and regulatory requirements. Conducted site visits and trained junior CRAs, contributing to a 90% success rate in meeting study milestones.

Data Validation Risk Assessment Communication Skills Project Coordination

Clinical Research Associate

Theorem Clinical

Mar 2011 - Apr 2014 (3 years 1 month)

Coordinated and managed clinical trials from initiation to close-out. Ensured compliance with regulatory requirements and maintained strong relationships with investigators and site staff.

Regulatory Compliance Patient Recruitment Communication Skills Risk Management Team Collaboration Project Management

Clinical Research Assistant

Advanced Pharma CR

Jun 2008 - Mar 2011 (2 years 9 months)

Assisted in planning and executing clinical research trials while ensuring compliance with protocols. Managed patient data and supported regulatory submissions, achieving a 90% on-time milestone completion rate.