Senior Data Manager_Remote @ US/CAN (Contract role)

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Requirements:

• Minimum BA/BS in scientific or health-related field.
• Minimum of 5 - 7 years of clinical data management experience in the pharmaceutical, biotechnology industry or in a CRO.
• Oncology or auto-immune experience required.
• Comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, etc.).
• Proficient with Medidata RAVE and familiarity with Medidata Suite products preferred.
• Excellent communication skills (verbal and writing).
• Ability to multi-task and take on new responsibilities in a fast-paced, small company setting.
• Experienced using Microsoft Office applications (Word, Excel, PowerPoint, etc.).
• Strong organizational skills and ability to prioritize tasks.
• Proven ability to work independently and in a team setting.

Responsibilities:

• Act as Lead Data Manager across one or more clinical studies and lead all aspects of data management activities.
• Provide expertise and oversight of all clinical database activities from design/start-up to closeout.
• Review protocols for appropriate data capture including electronic (eCRF) design.
• Support CRF design, review, and validation of the clinical database.
• Provide oversight of database set-up/migrations/upgrades including coordinating User Acceptance Testing.
• Conduct oversight of data management vendors and ongoing review of quality and performance metrics.
• Generate, resolve, and track data queries to ensure clinical data integrity.
• Facilitate and participate in data cleaning activities.
• Generate/review/approve various study documents related to data management.
• Review CRF metrics reports against project data deliverables.
• Maintain internal data management timelines and metrics, ensuring inspection readiness.
• Identify potential data management issues/risks and communicate within the study team.
• Participate in process improvement activities.