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.
• 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.

• 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.