Cassandra Leary

About Cassandra Leary

Manager, External Data in Clinical Data Management with 14+ years global experience in…

Experience

1. Manager, External Data

   eClinical Solutions

   Jul 2022 — Present

   Management of the lab admin team and developing the capability for the group to support the existing workload while building and expanding capability as necessary to support the growth of the organization. Collaborates with cross functional data stakeholders to develop and implement global standards for the collection, processing, reporting and analysis of external and local lab data. Develops and implements data strategies for reporting, review and monitoring of external, local lab and related data using analytics, listings and reporting tools. Collaborates and ensures UAT is performed for local lab eCRF to ensure Rave lab module is configured properly. Ensures range data entry and QC are performed in a timely manner consistent with requirements. Provides oversight and support of the lab admin team to research and resolve discrepant local lab range information. Serves as the lab data SME and cross functional liaison for external and local lab data processes. Ensures lab related deliverables meet/exceed project/study team expectations regarding quality, time and cost and that lab documentation is filed/archived according to applicable company and regulatory requirements. Develops, implements and executes strategies to allow Clients to better leverage their clinical data. Regularly presents updates on the status of the external and local lab initiatives to leadership team and others, as required. Interacts with multiple vendors including clinical CROs, lab vendors, IVRS, etc. on assigned projects to ensure data needs are met. Ensures compliance with company and industry quality standards, guidelines and procedures. Proactively addresses any/all issues as applicable. Acts as an SME and provides comprehensive external and local lab expertise to project/study teams to optimize study-specific clinical trial processes. Performs other duties as assigned.

Education

• Phoenixville Area High School

  High School

  2000 — 2003

• Technical College High School - Pickering Campus

  High School

  2000 — 2003

Skills

• Leading Meetings
• Interviews
• Phase 1 Clinical Trials
• Clinical Research
• Medidata
• Clo
• Electronic Data Management
• Edit Specifications
• Time Management
• Phase Forward Inform
• Process Improvement
• Dts
• Computer Proficiency
• Phase Ii Clinical Trials
• Microsoft Excel
• Powerpoint
• Data Entry
• Training
• Metrics
• Sas Eg
• Internal Resourcing
• Pharmaceutical Industry
• Client Focus
• Electronic Databases
• Query Writing
• Handle Multiple Projects
• Phase Iii Clinical Trials
• Electronic Filing
• Mentoring
• Handle Confidential Information
• Database Design
• Laboratory
• Team Management
• Clinical Data Management
• Oracle Clinical
• Documentation
• Multiple Therapeutic Areas
• Team Mentoring
• Microsoft Word
• Team Leadership