Job Description

Our Client is a dedicated pharmaceutical company focused on developing innovative medicines for cancer and beyond. With a lead program in development and a strong pipeline of potential products, our client is at the forefront of scientific breakthroughs in the industry.

Role Summary:

As the Director of Clinical Data Management, you will oversee all data processes related to assigned studies, ensuring the quality and integrity of all clinical data. Based in either San Francisco, CA, or Cambridge, MA, this role will involve managing data collection workflows, developing study plans, reviewing data specifications, and ensuring compliance with regulatory standards.

Responsibilities:

• Manage vendors involved in data management to ensure quality deliverables and timelines are met
• Design data flow processes across data sources and vendors in collaboration with stakeholders
• Develop study plans and protocols to meet data collection objectives
• Review specifications for database build, validation, and edit checks
• Ensure data quality through review and validation processes
• Provide expertise to study teams during project life cycles
• Lead a team of data management professionals
• Contribute to the development and review of Data Management SOPs and templates

Essential Skills & Experience:

• Bachelor's degree in science, biology, mathematics, or computer science
• CCDM certification preferred
• 15+ years of experience in clinical trial data management (oncology focused)
• Knowledge of clinical and data management regulations and guidelines
• Experience managing data management CROs
• Proficiency in Excel, relational databases, and data visualization tools
• Strong teamwork, communication, and problem-solving skills

Desirable Skills & Experience:

• Late-phase oncology trial experience
• PMP certification or knowledge of Project Management Principles
• Experience with EDC systems and CDISC standards
• Programming language skills (e.g., SAS, R, Python)
• Understanding of biomarker data curation

Call to Action:

If you are a highly experienced and passionate professional looking to make a significant impact in the field of clinical data management, we encourage you to apply by submitting your resume. Join Our Client in their mission to develop life-changing therapies and contribute to a culture of excellence and innovation.

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