Summary
Overview
Work History
Education
Skills
Core Competencies
Languages
Certification
Timeline
Generic

Olanike Omodara

Calgary,Alberta

Summary

Experienced and results-driven Clinical Research Professional with over 9 years of progressive experience in clinical trial oversight, global trial management, and team leadership. Proven expertise in oncology and rare disease clinical programs, including cell and gene therapies. Adept at cross-functional coordination, risk-based quality management, and driving operational excellence from study startup through closeout. Passionate about accelerating life-changing therapies to patients through clinical innovation and operational efficiency.

Overview

10
10
years of professional experience
1
1
Certification

Work History

Senior Clinical Lead

TRIO
03.2024 - Current
  • - Leading global oncology and rare disease clinical trials (Phase I-III) with emphasis on cell and gene therapy programs.
  • - Directing cross-functional teams to ensure timely and compliant execution of study activities.
  • - Reviewing and contributing to study protocols, ICFs, CRFs, and operational plans.
  • - Supporting PMs and sponsors with resource allocation and financial oversight of clinical deliverables.
  • - Presenting at bid defense meetings and supporting strategic proposal development.
  • - Championing risk-based quality management and adaptive monitoring practices across studies.
  • - Reducing site startup time in some cases by 22% through the implementation of a centralized feasibility assessment workflow
  • - Achieving 97% on-time visit completion rate across all assigned global sites.

Clinical Lead

TRIO
02.2022 - 03.2024
  • - Oversaw regional clinical trial activities, including CRA performance, data quality, and site support.
  • - Supported study start-up, protocol feasibility, and development of site training materials.
  • - Acted as primary contact for site escalations, coordinating resolutions with PM and sponsor.
  • - Analyzed trends in protocol deviations, action items, and site communications to improve performance.
  • - Contributed to risk mitigation strategies and ongoing assessment of clinical trial progress.
  • - Improved protocol adherence by 18% through enhanced site engagement and training.
  • - Managed over 40 investigator sites across North America with

Senior Clinical Research Associate (Senior CRA)

TRIO
06.2019 - 02.2022
  • - Conducted site monitoring visits for rare disease and oncology studies across multiple regions.
  • - Ensured GCP and protocol compliance through comprehensive site evaluations and training.
  • - Mentored junior CRAs and supported internal CRA training initiatives.
  • - Assisted with the development of monitoring plans, risk logs, and sponsor reports.
  • - Collaborated closely with Clinical Leads and Data Managers to ensure data integrity and timelines.
  • - Maintained 100% monitoring visit compliance and reduced protocol deviation rates by 12%.
  • - Trained 10+ junior CRAs who successfully advanced to independent monitoring roles.

Clinical Research Associate (CRA)

ICON
08.2015 - 05.2019
  • - Performed full cycle monitoring (initiation, routine, close-out) for Phase I-III clinical studies.
  • - Supported investigator site selection and qualification activities.
  • - Reviewed source documents and CRFs to verify data accuracy and regulatory compliance.
  • - Built strong site relationships, enhancing recruitment and retention across study duration.
  • - Maintained accurate study documentation and reported findings to the sponsor team.
  • - Increase site compliance score by 15% via proactive follow-up and root cause training.
  • - Supported recruitment activities contributing to a 10% increase in enrollment over target.

Education

Advanced Certificate - Health Leadership

British Columbia Institute of Technology
Burnaby, BC
12-2024

M.D. - Medicine

Gomel State Medical University
Belarus
06-2013

Skills

  • EDC Systems (Medidata Rave, Veeva Vault), CTMS (Oracle Siebel, Medidata CTMS, Veeva CTMS), Risk Management Tools, MS Office Suite (Word, Excel, PowerPoint, Outlook), Clinical Metrics & Dashboards

Core Competencies

Global Clinical Trial Management, Oncology, Rare Disease & Gene Therapy Expertise, Cross-functional Team Leadership, Study Startup & Site Activation, Protocol & Document Review, Risk-Based Monitoring (RBM), Financial Oversight & Budgeting, Clinical Operations Strategy, Stakeholder Communication, Bid Defense & Sponsor Presentations

Languages

English
Full Professional
Russian
Professional Working

Certification

  • GCP & ICH Guidelines – Current
  • Clinical Project Management

Timeline

Senior Clinical Lead

TRIO
03.2024 - Current

Clinical Lead

TRIO
02.2022 - 03.2024

Senior Clinical Research Associate (Senior CRA)

TRIO
06.2019 - 02.2022

Clinical Research Associate (CRA)

ICON
08.2015 - 05.2019

Advanced Certificate - Health Leadership

British Columbia Institute of Technology

M.D. - Medicine

Gomel State Medical University

Similar Profiles

CREATE PROFILE
Olanike Omodara