Daniel H. Email & Phone Number

Summerville, Sc, Us

• Design and program databases in RAVE EDC for clinical trials of various sizes (Phase 1- Phase 4) on both commercial and federally funded studies. Responsibilities include eCRF design, edit check logic programming, visit structure and database dynamics.• Represented EDC Programming in various departmental initiatives to streamline our start-up process and reduce timelines, develop CDISC-compliant database standards, and developed departmental UAT guidelines.• Manage and perform study migrations and mid-study updates.• Create study documentation such as Data Plan (DVP), Edit Check Specifications, eCRF Completion Guidelines, and more.• Represent EDC Programming and Data Management at sponsor meetings, study startup meetings, and database user trainings.• Managed user acceptance testing (UAT) and all relevant documentation.

• Design, build and manage clinical trial databases for bio-pharmaceutical organizations; eCRF and ePRO design, edit check logic programming, visit structure and database dynamics.• Data Management study lead through the entire life cycle of a Clinical Trial; Protocol inception to final dataset delivery.• Create study documentation; data management plan, data validation plan, edit check specifications, eCRF completion guidelines, and more. • Study database design in a number of EDC platforms, including Medidata RAVE and IBM Clinical Development. Build user acceptance testing documentation and process.• Presenter for Sponsor Meetings, Site/SIV EDC Training, and database user trainings.• Study data validation planning, testing and reporting.• IWRS programming and management; Investigational Product management and dispensing, patient randomization.• Design and build custom reports for data tracking, cleaning and analysis.

• Compiled the electronic Trial Masterfile for pharmaceutical and medical device trials.• Ensured regulatory database was compliant with GCP and GDP.• Performed ongoing QC review of regulatory documents.

Charleston, South Carolina Area

• Created and conducted experiments exploring various methods of organ preservation in a start-up environment.• Analyzed data and wrote reports for peer reviewed publication.• Wrote SOPs, established workflows, and helped manage the financial operations of the lab.