Description

You will oversee all data management activities for clinical trials, from document development to database lock. Responsibilities include managing timelines, generating study documents, leading data reviews, and coordinating with CROs. You'll ensure data integrity and regulatory compliance while supporting cross-functional teams.

Requirements

• Bachelor's degree in health sciences, life sciences, mathematics, computer sciences, or related field
• At least 5 years of clinical data management experience in pharmaceutical or biotech industry
• Solid knowledge of clinical data management principles, clinical trial process, and regulatory requirements
• Good working knowledge of ICH, FDA, and GCP guidelines

Responsibilities

• Represent data management in study team meetings and provide updates
• Manage data management timelines and synchronize deliverables
• Generate and review study documents (DMP, CRF, DB specs, data transfer specs, reconciliation plans, coding conventions, lab data handling plans, protocols)
• Lead internal Data Review Plan and coordinate cross-functional data listing review
• Provide oversight of CRO/service providers and monitor DM activities