Marvin N.

About Marvin N.

Clinical Research Professional with over a decade of experience in managing clinical research studies for biotechnology, pharmaceutical, and medical device development.My core competencies include site management, risk-based monitoring, remote monitoring, budget tracking, project management, and FDA audit preparation and responses. I am proficient in using various clinical trial software and tools, such as CTMS - Impact, BioClinica, Veeva, Advantage eClinical eSVR; EDC - Inform, Advantage eClinical, Medidata Rave; eTMF - Veeva vault, Florence, Complion, Box, SharePoint; others ERT, Signant IRT/Bracket IWRS, Trifecta InvestigatorSpace, Concur, eICF, eCOA, eCRF, and MS Office. I have experience working in various therapeutic areas, such as Oncology, Neuroscience, Ophthalmology, Infectious diseases, Medical devices, Cardiovascular, and Rare diseases.

Experience

1. Principal Clinical Research Associate

   Ppd

   Mar 2024 — Present

   Verify data in source documents agree with source, initiate data query resolution and confirm resolution in timely manner.• Ensure that the assigned trial site complies with the study protocol, GCP, and applicable regulatory requirement for performingstudy activities.• Relationship building with Investigator and site staff by being the main point of contact for questions, liaising with andescalating to the appropriate teams to respond and resolve questions.• Administer protocol and related study training to assigned sites and established regular lines of communication with sites tomanage ongoing project expectations and issues.• Perform and document pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and studyclose out visits in accordance with GCP, study-specific requirements, clinical monitoring plans, Organizational SOPs,applicable regulatory requirements, and defined quality and performance standards.• Perform all types of visits.(PSSV, SIV, IMV & COV.• Manage investigational product supplies to trial site. Keep track of drug lots/batches and expiration dates and assist ininvestigational product forecasting in accordance with study agreements.• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functionalareas.

Education

• Coventry University

  Master of Science - MSc

• Imo State University

  Bachelor's degree, Microbiology