S. Dana Oley Email & Phone Number

Denver, CO, US

Colorado, United States

• Took a planned hiatus to focus on wellness and pursue personal goals
• Volunteers as an instructor for Colorado Mountain Club’s Technical Climbing School, training students in technical mountaineering, rock climbing, rescue, snow travel, and navigation

Raritan, NJ

• Led multiple cross-functional processes surrounding the Veeva Vault eTMF system, including Completeness Quality Review, Central Import filing, eTMF Inspection, TMF Quality and Metrics, and onboarding of TMF Analysts
• Developed, optimized, and managed TMF processes, maintaining ongoing collaboration with stakeholders and senior leadership to ensure business requirements were met and to ensure compliance to regulations and guidelines
• Member of Core Team for the planning of eTMF system releases, collaborating on proposed system enhancements to identify potential risks and determine change management requirements
• Evaluated system release impact assessments for impact to TMF Template, TMF quality and metrics reports, business processes, inspection processes, existing metadata, controlled documents, and training materials
• Coordinated with eTMF vendor on configuration of system enhancements and bug fixes, to include communication of business requirements, strategizing, and performing sandbox and post-release testing
• TMF Analyst lead for regulatory authority inspection and GCP audit activities surrounding eTMF

Skillman, NJ

• Prepared product specifications and data for migration into new electronic Document Management System (EDMS)
• Performed QC review of documents to identify issues and errors and revised documents or escalated as needed
• Identified reference document and parent-child document relationships for inclusion in migration
• Reconciled metadata fields against reference documents

• Supervised Product Release and Quality Control Inspection teams
• Reviewed and approved Device History Records (DHRs), nonconformances, risk assessments, validations, and SOPs
• Investigated and addressed quality issues, internal audit findings, nonconformances, and CAPAs
• Coordinated with vendors, distribution centers, and customers regarding quality issues, product recall, and rework

• Independently managed central laboratory services for Phase I-IV global clinical trials
• Served as the central laboratory liaison between the Sponsor and all internal departments
• Configured protocol amendments and updated study information in multiple systems
• Performed thorough quality reviews on set up documentation for new studies
• Managed and maintained version control of trial files, including protocols, agreements, requisitions, investigator manuals, communication plans, hard copy and electronic communications, reports, specifications, and memos
• Responded to study specific inquiries from sponsors, physicians, CRAs, and CRO representatives

• Represented the single point of study control, including the technical conduct, documentation, data analysis, interpretation, and final reporting of preclinical studies for submission to regulatory agencies
• Supervised technical staff and daily laboratory operations, including review of laboratory documentation, data, trackers, and equipment and sample logs
• Created and finalized protocols, study reports, and SOPs in compliance with GLPs and testing guidelines
• Documented and investigated protocol deviations and implemented corrective actions
• Collaborated with sponsors, internal departments, upper management, and field experts daily

• Managed the daily operations of the Quality Laboratory in providing contract medical device sterilization services
• Performed QC review all processing documentation and experimental data for accuracy and completeness
• Reviewed and updated SOPs to ensure compliance to GMPs and ISO standards
• Provided support during FDA and customer audits