Lead, Clinical Data Management (Oncology)

Summit Therapeutics, Inc.; Palo Alto (CA); On-site; USD 174,000 - 204,000; Full time

Job summary

Summit Therapeutics Inc. is seeking an experienced Associate Director, Clinical Data Management to lead data management activities across diverse clinical trials in oncology.

You will drive CDM strategy, oversee eCRF design and data flow, and ensure data integrity and regulatory compliance with internal and external partners. The role requires collaboration with Biostatistics, Clinical Operations, Regulatory, and IT to deliver high-quality data for analysis while optimizing processes and

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, or relevant field; or equivalent practical experience
• A minimum of 10+ years of Clinical Data Management experience in biotechnology or pharmaceutical industry with oncology exposure
• Experience with various data collection and Electronic Data Capture (EDC) systems and understanding of coding processes
• Strong track record of line management and supervisory experience of CDM staff
• CRO and vendor oversight experience preferred

Responsibilities

• Provide strategy and development guidance for Clinical Data Management portfolios to ensure data quality and milestones
• Lead systems and processes for data security, integrity, and regulatory alignment
• Manage data management across early to late phase trials in large or complex programs
• Develop and implement CDM standards, data plans, transfer agreements, and data flow processes
• Oversee CROs, vendors, and technology for CDM activities
• Lead eCRF design, specifications, testing, queries, reconciliation, data migration, and database closeout
• Collaborate with Clinical Operations, Biostatistics, Regulatory, and IT to align data management activities
• Support cross-functional teams to resolve data management questions and mitigate risks
• Work with leadership to optimize efficiency, costs, and quality
• Ensure compliance with FDA regulations and GCP/ICH guidelines

Skills

CDM leadership

Oncology experience

FDA/ICH knowledge

Cross-functional collaboration

Vendor oversight

Education

Bachelor’s degree in Life Sciences, Computer Science, or relevant field

Tools

EDC systems

Data standards

Job description

Summit Therapeutics Inc. is seeking an experienced Associate Director, Clinical Data Management to lead data management activities across diverse clinical trials in oncology.

You will drive CDM strategy, oversee eCRF design and data flow, and ensure data integrity and regulatory compliance with internal and external partners. The role requires collaboration with Biostatistics, Clinical Operations, Regulatory, and IT to deliver high-quality data for analysis while optimizing processes and