Daniel Nwosu

About Daniel Nwosu

Dynamic and passionate professional with comprehensive experience in managing full study start-up process through site activation, site management to close out. Proven success in implementing study activation plans, delivering customized training, streamlining CRO oversight processes, enhancing data integrity, and driving improvements across clinical sites. Adept at organizing sponsor meetings aligned with study milestones, operational targets, and risk mitigation strategies. Expert at employing business development efforts through proposal and bid defense contributions, optimizing study delivery, and collaborating with diverse teams to attain set goals. Skilled in resolving study start-up challenges, ensuring seamless site initiation, and adhering to regulatory requirements.Areas of Expertise Meeting Planning & Logistics Support Data Monitoring & Issue Management Clinical Site Monitoring & Reporting Study Start-Up Site Activation Site Management & Close- Out Clinical Project Management ICH/GCP & SOPs Compliance Budget & Financial Management Investigator & Site Staff Training Study Materials Coordination

Experience

1. Senior Cra (in House) Clinical Operations

   I-Mab Biopharma

   Apr 2022 — Present · MD, US

   Enhanced project efficiency by assisting clinical project manager on study tasks to ensure an organized study progress. Optimized vendor and site performance through proactive assistance in site and vendor identification, oversight, and financial management. Facilitated informed consent and regulatory compliance by preparing and distributing consent documents to sites and submitting them to IRB. Provided project transparency by preparing updates, attending team meetings, and reporting on project status and site-specific performance. Ensured timely delivery and tracking of essential study materials (CRFs, diaries, cards, supplies) through efficient coordination. Boosted data integrity by managing CTMS entries and overseeing TMF set-up, maintenance, and quality control checks for assigned studies. Contributed to process improvements by aiding in development of Clinical Operations systems to refine internal workflows and boost efficiency.• Drove study progress through comprehensive management of start-up and site activities from initiation to close-out by implementing corrective actions as per requirements.• Streamlined study activation by collaborating closely with budgeting, contracting, regulatory, and site management teams to implement activation plans.• Maintained study tracking by utilizing monitoring systems for regulatory submissions, site readiness, and activation status.• Reduced data discrepancies by providing oversight and resolution of data issues with CROs, clinical sites, and vendors.• Improved clinical monitoring accuracy by overseeing CRAs, approving site monitoring reports, and resolving queries.• Ensured compliance and accelerated site activation by reviewing and approving regulatory documents meticulously.• Minimized delays by identifying project issues early, offering solutions, and proactively managing study challenges.

Education

• Walden University

  Master’s Degree, Clinical Research Administration

  2014 — 2016

Skills

• Clinical Research
• Protocol and Protocol Deviation Submissions to Irbs
• Medicine
• Data Entry Into Edcs and Query Resolutions
• Clinical Research Administration
• Microsoft Office
• Subject Enrollment and Retention
• Review and Handling of Study Specific Regulatory Documents
• Development and Review of Informed Consent Forms
• Subject Recruitment
• Good Clinical Practice (Gcp)
• Submission and Annual Renewal of Clinical Studies to Irb
• Maintenance of Tmf and Start-Up Regulatory Doduments
• Clinical Trials
• Code of Federal Regulations, Ich/Gcp and Fda Guidelines
• Icf Customization
• Immunology
• Institutional Review Board (Irb)
• Site Initiation Visits, Site Monitoring Visits and Close Out Visits
• Clinical Trial Management System (Ctms)
• Protocol
• Data Collection, Compilation, Documentation and Analysis