Nikita Oigbokie
Memphis,TN
Summary
Clinical research leader with 20yrs of progressive experience across site-level coordination and clinical operations management. Proven expertise in global study start-up, regulatory document oversight, cross-functional team leadership, Scientific Leadership, and client-facing project execution. Known for driving timelines, ensuring regulatory compliance, and collaborating with CROs and Sponsors to accelerate study activation. Adept in ICH-GCP, FDA regulations, and CRO systems like ClinPlus, Veeva Vault, Medidata, Florence and Rave.
Overview
27
27
years of professional experience
Work History
Clinical Operations Manager - Study Start-Up
Emerald Clinical
05.2015 - 06.2025
- Company Overview: Asia Pacific
- Lead the study start-up (SSU) team supporting global Phase I-III clinical trials across multiple therapeutic areas.
- Oversaw submission timelines for site regulatory packages, IRB approvals, and essential documents across 25+ global sites.
- Managed, recruited and trained study start-up specialists, coordinating with contracts, feasibility, and regulatory affairs.
- Acted as primary liaison with sponsors and global CROs, ensuring all start-up milestones were met on time and within scope.
- Developed and implemented SOPs to streamline the activation process and reduce site initiation delays by 20%.
- Tracked KPIs including cycle times, first-patient-in targets, and document compliance metrics.
- Scheduled weekly meetings with Project Managers to discuss project deliverables, issues, SSU team allocations and activities.
- Implemented assigned projects to the SSU team.
- Performed billable project tasks as needed.
- Responsible for local administration and business operations of Emerald Clinical entity.
- Provided regular information to Line Managers at the country level on study and planned study milestones/key issues during the start-up period.
- Actively participated in Local Study Team (LST) and Sponsor meetings.
- Provided feedback on any research-related information including sites/investigators/competing studies that might be useful for the local market.
- Asia Pacific
Principal Clinical Trials Specialist
Emerald Clinical
05.2015 - 01.2021
- Company Overview: Asia Pacific
- Accountable for study start-up and regulatory maintenance, including the collection, preparation, reviewing, and tracking of documents for the application process.
- Responsible for writing SSU Plans, TMF Plans, and other plans as needed.
- Worked closely with Project Managers to discuss project timelines, deliverables, and to resolve issues.
- Accountable for preparing meeting agendas and minutes.
- Conducted feasibility process for proposed and assigned clinical projects.
- Supported legal groups in the negotiation of clinical trials contracts.
- Provided training and development to new employees.
- Provided administrative and logistical support to the SSU operations team, handling eTMF uploads.
- Accountable for site CTA amendments, reviews and executions, site binder preparations, and correspondence with central IRBs (Advarra, WCG).
- Supported CRA visits by preparing regulatory documentation and resolving follow-up action items.
- Asia Pacific
Clinical Research Associate I
St. Jude Children's Research Hospital
08.2004 - 12.2008
Sr. Research Associate
University of Tennessee Health Science Center
08.1998 - 10.2003
Education
Bachelor of Science - Medical Technology
Baptist University
Memphis, TN01.2014
Masters of Science - Clinical Research Administration
Walden University
Minneapolis, MN01.2012
Bachelor of Science - Biology
LeMoyne-Owen College
Memphis, TN01.1994
Skills
Global Study Start-Up and Study Closure Oversight
Regulatory Document Management (IRB, ICF, CTA, FDFs)
Site Activation Strategy
Cross-Functional Team Leadership
Client & Sponsor Communication Skills
CTMS/eTMF/QC Oversight (Veeva, ClinPlus, Florence, Trial Interactive)
CRO Compliance
Process Optimization & SOP Development
Risk Identification & Mitigation
Budget Management & Timeline Tracking
Staff Management and Utilization Reviews
EDC: Medidata Rave & REDCap
Associate of the Month Award; Employee Service Award; and GARP Performance and Value Award
-In August of 2016 recognized and received an award for performance.
- In May of 2017 I received the 1yr service and performance award
-In September of 2018 I received the GARP award which recognized employee performance and company values
Timeline
Clinical Operations Manager - Study Start-Up
Emerald Clinical
05.2015 - 06.2025
Principal Clinical Trials Specialist
Emerald Clinical
05.2015 - 01.2021
Clinical Research Associate I
St. Jude Children's Research Hospital
08.2004 - 12.2008
Sr. Research Associate
University of Tennessee Health Science Center
08.1998 - 10.2003
Bachelor of Science - Medical Technology
Baptist University
Masters of Science - Clinical Research Administration
Walden University
Bachelor of Science - Biology
LeMoyne-Owen College
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