Senior Manager, Clinical Data Management

Role Summary

Senior Manager, Clinical Data Management

Responsibilities

• Act as the lead data manager across one or more clinical studies.
• Provide expertise and oversight of all clinical database activities from design/start-up to closeout.
• Reviews protocols for appropriate data capture including electronic (eCRF) design.
• Support CRF design, review, and validation of clinical database.
• Provides oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.
• Conducts oversight of data management vendors via ongoing review of quality and performance metrics.
• Generates, resolves, and tracks data queries to ensure the integrity of the clinical data.
• Facilitates and participates in data cleaning activities.
• Generates and/or reviews/approves study documents.
• Responsible for maintaining internal data management timelines and metrics. Maintains study DM related documents/files for inspection readiness.
• Proactively identifies potential data management issues/risks and communicates it within the study team for further action.

Qualifications

• Minimum BA/BS in scientific or health-related field.
• Minimum of 7 years of clinical data management experience in the pharmaceutical, biotechnology industry or in a CRO.
• Oncology trial experience required, hematology/oncology preferred.
• Possesses a comprehensive understanding of regulatory guidelines and industry standards.
• Proficient with Medidata RAVE; experience working on Medidata Suite products preferred.
• Familiarity with various data visualization, analytics, and reporting tools is a plus.
• Excellent communication skills, strong organizational skills, and ability to work independently and effectively prioritize tasks in a fast-paced setting.