Dan O'Connell Email & Phone Number

Wake Forest, North Carolina, United States

Lead the growth and expansion of Yonalink's EHR steaming technology across the clinical research industry.

Wake Forest, North Carolina, United States

Wake Forest, North Carolina, United States

Our mission at eClinical Solutions is to make clinical data acquisition, standardization, aggregation and analysis absolutely simple and easy. We provide end to end data management solutions leveraging our cloud-based, clinical data repository platform called elluminate®. The entire research team is supported by elluminate: it enables pro-active data management through advanced visualizations and analytics; provides clinical insights for the clinical and medical staff, including reports for risk based monitoring; supports the regulatory team with submission ready data; and reduces the burden on the programming team to create ad-hoc queries and reports.

Raleigh-Durham, Nc

Connecting Life Sciences companies to the industry's most comprehensive, unified platform to help bring therapies to patients faster & smarter.

Remote - Wake Forest, Nc

Working to shape and help execute Medidata's Risk Based Monitoring and Central Statistical Analysis go-to market strategy.

Raleigh-Durham, North Carolina Area

Driving innovation through development and adoption of new processes and systems that improve clinical trial operational efficiency, quality, and patient safety by leveraging the use of business analytics, data visualizations and in-depth clinical knowledge and expertise. Serve as a subject matter expert in delivery of Risk Based Monitoring (RBM) strategies and solutions to both internal business champions as well as external customers. Provide customers (small biotech to large pharma) with overarching RBM methodology and technology implementation that is “fit for purpose” at a customer/project level. Collaborate and develop with industry leading technology/software providers. Evaluate & utilize vendor applications to support strategy and meet customer needs.

Remote Office - Nc

Head of CTMS, EDC, eTMF and related global platforms for all Clinical Research users in the US. Worked with key stakeholders at a global & local level to build consensus across departments (Quality, IT, Training, etc.) in the development of integrated solutions for immediate and long range needs. Developed, distributed & reviewed clinical study performance reports with study teams to measure and improve metrics & KPI. Define and institute processes to improve quality, compliance and operational performance. Coach, mentor & motivate team of “Super Users” to provide customer service and support across clinical applications for 400+ users. Primary trainer for both new hire on-boarding and study-aligned process/application training. Led team of “Super Users” to provide customer service & support across clinical applications. Integral team member for the development, implementation and rollout of a global CTMS solution.

Full service Site Manager for 25+ clinical trial sites (Phase II & III) across various therapeutic areas (cardiovascular, diabetes/metabolism, CNS) responsible for all aspects of clinical trial process. Lead CRA on select studies responsible for development, training and implementation of monitoring plan, study tools and manuals. Served as a CRA mentor and trainer of new hires. Led team of CTMS “Super Users” responsible for direct support and issue resolution for 200+ users. Served as liaison between global CTMS team and Clinical Operations to provide continual process improvement on CTMS and reporting applications. Member of IMPACT User Group (Perceptive Informatics).

Lead CRA responsible for all phases of study management (feasibility through close-out) for multiple investigational sites for various therapeutic areas (respiratory, diabetes, anti-infectives, cardiovascular, pediatrics, arthritis) in accordance with local regulations, GCP and ICH guidelines. Original member of the first regional monitoring team at Aventis. Performed training and mentoring of new employees during growth of monitoring team from 18 to 60+ employees.

Research Triangle Park, Nc

Independently monitored multiple Phase I, II & III clinical trial sites across various therapeutic areas (oncology, metabolism, pediatrics, cardiovascular, gene therapy). Served as liaison between sponsor and study sites, reviewed site contracts/budgets and attended project meetings. Obtained ACRP certification for Clinical Research Associate.

Research Triangle Park, Nc

Managed a multi-center clinical trial and maintained trial database. Coordinated and tracked project team activities, correspondence and regulatory documents. Established and maintained complex project files, budgets and timelines. Participated in sponsor meetings.