Clinical Trial Management Associate II

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 

Job Description/Experience: 

• 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.

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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