Senior Manager, Clinical Data Management

Role Summary

Senior Manager, Clinical Data Management leading data management across one or more clinical studies, providing oversight of all clinical database activities from design/start-up to closeout, and ensuring data integrity and inspection readiness.

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.
• Review protocols for appropriate data capture including electronic (eCRF) design.
• Support CRF design, review, and validation of clinical database.
• Provide oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.
• Conduct oversight of data management vendors via ongoing review of quality and performance metrics.
• Generate, resolve, and track data queries to ensure the integrity of the clinical data.
• Facilitate and participate in data cleaning activities.
• Generate and/or review/approve study documents.
• Maintain internal data management timelines and metrics; maintain study DM related documents/files for inspection readiness.
• Proactively identify potential data management issues/risks and communicate them within the study team for further action.

Qualifications

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

Skills

• Strong communication and collaboration abilities
• Excellent organizational skills
• Ability to work independently and prioritize tasks

Education

• BA/BS in scientific or health-related field