Debra Jendrasek

About Debra Jendrasek

Committed, passionate problem solver with exemplary follow-through. Positively applies skills and expertise that further the business priorities. Keen ability to understand, capture and interpret needs of customers. Excellent at reaching out across departments and working with the teams to drive resolutions that focus on the client expectations and company deliverables. Actively seeks out opportunities to gain insights on developments and emerging trends through external networks, bringing ideas and innovations back within the organization.

Experience

1. Director, Risk Based Data Monitoring & Validation

   Daiichi Sankyo US

   Feb 2024 — Present · Wilmington, NC, US

   Accountable for leading Daiichi’ Sankyo\'s Data Monitoring and Validation Strategy. Establish and maintain a connection between the identification of Critical to Quality data and processes, the Risk Assessment, and Data Validation with the goal of increasing data-driven data quality. Drive the functional areas to adopt a data mindset that enables better data, for faster database locks.Utilize visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation and improvement.

Education

• Bentley University

  BS, Computer Information Systems

  1982 — 1986

Skills

• Clinical Development
• Ich-Gcp
• Data Management
• Clinical Trial Management System (Ctms)
• 21 Cfr Part 11
• Biotechnology
• Gcp
• Regulatory Submissions
• Pharmaceutical Industry
• Sop
• Fda
• Training
• Clinical Research
• Oncology
• Clinical Trials
• CRO
• Life Sciences
• Regulatory Affairs
• Lifesciences
• Electronic Data Capture (Edc)
• Edc
• Ctms
• Clinical Data Management
• Pharmacovigilance