Victor Anyanwu
Overview
9
9
years of professional experience
Work History
Clinical Trial Manager
RHO
01.2018 - 11.2021
- Collaborates with Project Management to set site management monitoring strategy and ensures compliance with project goals and Worldwide processes
- Provides leadership to clinical site management team members from study start through to closure
- Serves as Site Management (SM) primary point of contact for clinical monitoring and site activities within the project
- Attends Investigator and Bid Defense Meetings
- Hosts Internal and External study team calls.
Senior Clinical Research Associate
RHO
01.2016 - 01.2018
- Maintained current and accurate protocol documentation; notified investigators of pertinent protocol changes
- Maintained and completed regulatory documents for IRB
- Compiled and submitted data on appropriate forms according to protocol requirements
- Established and maintained interpersonal relationships with patients, visitors and other hospital personnel, while assuring confidentiality of patient information
- Collected and delivered specimens for analysis, using appropriate or specified equipment for collecting and handling specimens; ensured proper labeling and obtained pertinent clinical and protocol information on request forms; developed and maintained knowledge of various aspects of processing specimens, paying particular attention to safety practices
- Worked on special data management projects as assigned
- Worked with physician or nurse to see that protocol related tests and evaluations were ordered per protocol guidelines
- Played active role in recruitment of patients to study
- Worked with supervisor to ensure performance of appropriate levels of quality.
Clinical Research Associate II
Merck
03.2015 - 01.2016
- Participated in and facilitated cross-functional study teams, liaised with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory affairs) to accurately coordinate clinical study activities
- Coordinated clinical study timelines with Project management to meet critical milestones; escalated issues that may jeopardize timelines and deliverables
- Provided monitoring oversight by reviewing monitoring schedules, metrics and reports
- Oversees or manage clinical documentation and reports
- Accurately updated and maintained clinical systems within project timelines
- Provided regular updates of study progression to CTM, Clinical Development Lead, Program Management, and other stakeholders
- Proactively identified and resolved issues that arise during study conduct; manage escalation of study-related issues
- Participated in developing study plans and system setup; participated in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
- Implemented appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintained clinical study files per ICH guidance
- Participated in preparation of vendor requirements and project scope and selection of study vendors; effectively managed interactions with vendor study team
- Created and conducted training sessions including investigator meetings and team trainings.
Clinical Research Associate I
Merck
01.2013 - 03.2015
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity
- Followed drug storage procedures to comply with protocols and SOP requirements
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval
- Established drug trial methodologies and procedures to support business and clinical trial endeavors.
Education
Bachelor of Science Chemical Engineering -
North Carolina Agricultural And Technical State
Greensboro, NCTimeline
Clinical Trial Manager
RHO
01.2018 - 11.2021
Senior Clinical Research Associate
RHO
01.2016 - 01.2018
Clinical Research Associate II
Merck
03.2015 - 01.2016
Clinical Research Associate I
Merck
01.2013 - 03.2015
Bachelor of Science Chemical Engineering -
North Carolina Agricultural And Technical State
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