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
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.