Tech Stack

Description

You will lead clinical data management activities for multiple studies, oversee outsourced CRO deliverables, manage data collection tools and essential documents, and ensure data quality and integrity. Your work will directly support the development of innovative protein degradation therapies.

Requirements

• 8+ years clinical data management experience in biotech or pharma with CRO oversight
• 5+ years managing vendor relationships/partnerships in a global environment
• Advanced knowledge of Data Management processes and systems
• Solid understanding of CDISC standards
• Experience with MedDRA and WHODrug terminology

Responsibilities

• Act as Lead Data Manager overseeing outsourced DM CRO activities for multiple studies
• Manage relationships with functional areas to ensure high quality data management
• Oversee data collection tools (EDC, DTAs, integrations) and essential documents (DMP, UAT, data edit specs, annotated case books, entry guidelines)
• Participate in User Acceptance Testing for data collection tools and perform QC for data completeness and accuracy
• Contribute to development of best practices, SOPs, and process improvement initiatives