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
Similar Profiles
SEONG MING CHUASEONG MING CHUA
Clinical Research Associate 1 at Emerald Clinical Trials Asia Pacific LimitedClinical Research Associate 1 at Emerald Clinical Trials Asia Pacific Limited
Nur Amalina AnnuarNur Amalina Annuar
Senior Clinical Trial Specialist at Emerald Clinical Trials Asia Pacific LimitedSenior Clinical Trial Specialist at Emerald Clinical Trials Asia Pacific Limited
Meghan SwardstromMeghan Swardstrom
Principal Consultant at Emerald Clinical Consulting, LLCPrincipal Consultant at Emerald Clinical Consulting, LLC
Jamarr D. StackensJamarr D. Stackens
Personal Security Specialist at Jerry Lee LewisPersonal Security Specialist at Jerry Lee Lewis
Maurice BlandMaurice Bland
Home Improvement Contractor at Self-employedHome Improvement Contractor at Self-employed