Title: Clinical Trial Management Associate II
This person is to be responsible for the MANTA/MANTA-RAy semen analysis (SA) data entry and results processing. As an overview, this person would be responsible for:
1. Ongoing awareness of all ongoing SA visits (requests, ongoing, completed, overdue)
2. Process SA forms for all collections, review and data entry in EDC
3. Liaise with ClinOps, ClinResearch, Biostats, DM or Tulane for any issues arising from review of SA forms
4. Work with Biostats to ensure results are QC’d
5. Review resulting templates for accuracy
6. Draft CRO email with results and attach all required forms
7. Send result email to CRO and/or Galapagos
8. Complete various SA trackers documenting SA information in a timely basis
9. Provide updates/metrics to team as needed
• Experience performing data entry from source documentation
• Assists in implementing routine activities and supports development of process improvement, if applicable
• Identifies, tracks, and resolves routine queries and issues.
• Demonstrates ability to identify problems early and communicate escalation issues appropriately.
• Capable of conducting assigned tasks independently.
• Effectively interacts and collaborates with Functional Areas representatives meet study deliverables and timelines for quality checking and reporting.
• Ensure completeness, accuracy and consistency of clinical data entry and reporting.
• Utilizes routine reports to track activity progress and ensures timeliness and quality expectations are met.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Knowledge of FDA/EMA regulations and familiarity with web-based Electronic Data Capture (EDC) is a plus
• Strong attention to detail and organizational skills, able to track and prioritize day to day activities
• Proficient with Microsoft Office, in particular Outlook and Excel. Knowledge of Excel pivot tables, formulas a plus.
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