Katrina Banyas
- Role
- Clinical Study Manager at Beigene
- Location
- Baton Rouge, LA, US
- LinkedIn followers
- 500 followers
About Katrina Banyas
Over a decade of experience in clinical research. Eight years of clinical study…
Experience
Clinical Study Manager
May 2022 — Present
Acts as regional lead for large global lung studies. Contributes to the content and review of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICFs, monitoring visit reports, etc. Coordinates with supply operations regarding drug forecasting and supply of study drug/comparator drug to sites. Performs oversight of Central Lab, IRT and other ancillary vendors during start-up, conduct, and close-out. Assist in the set-up and performs oversight of the eTMF according to ICH-GCP and company SOPs. Ensures all documentation is in a state of audit readiness. Prepares study related documents, i.e. clinical trial tools, trackers and templates. Assists with vendor management during the coordination of Investigator Meetings. Contributes to and reviews changes in scope and change orders. Actively participates in the development of department initiatives; contributes ideas (when asked) on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations.
Skills
- Phase Forward Inform
- Social Networking
- Strategic Planning
- Clinical Research
- Sae Reconciliation
- Medical Research
- Independent Contributor
- Marketing Strategy
- Sales Management
- Robotic Surgery
- Account Management
- Protocol Review
- Leadership
- Sales Operations
- Time-Efficient
- Remote Data Capture
- Clinical Trial Management System (Ctms)
- Cancer Research
- Oracle Rdc
- Regulatory Submissions
- Microsoft Powerpoint
- Medidata
- Site Initiation
- Time Management
- Protocol Implementation
- Drug Accountability
- Safety Monitoring
- Customer Service
- Adverse Event Reporting
- Sales Effectiveness
- Subject Recruitment
- Protocol Designing
- Informed Consent
- Inform
- Marketing
- Sales
- Study Monitoring
- Microsoft Word
- Good Clinical Practice (Gcp)
- Social Media
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