Associate Director, Clinical Data Management — Oncology

Summit Therapeutics, Inc.; Palo Alto (CA); On-site; USD 174,000 - 205,000; Full time

Job summary

Summit Therapeutics, Inc. is seeking an Associate Director, Clinical Data Management to lead data management for global oncology trials.

You will direct CRF/eCRF design, database development, data validation, query resolution, and database lock, while coordinating with Biostatistics, Regulatory, and IT teams to ensure high-quality data. This senior role entails managing CDM staff and CROs, establishing standards, ensuring FDA/ICH compliance, and driving process improvements to deliver reliable

Qualifications

• 10+ years of Clinical Data Management experience in biotechnology or pharmaceutical industry, oncology preferred.
• Experience with various EDC systems and coding processes (MedDRA/WHODRUG).
• Strong leadership, communication and vendor management skills.

Responsibilities

• Lead data management for global oncology trials across early to late phase programs.
• Direct CRF/eCRF design, database development, validation programming and data review.
• Oversee discrepancy management, SAE reconciliation, and database lock.
• Manage CDM staff and CROs; coordinate with Biostatistics, Regulatory, and IT.
• Develop and enforce CDM standards, data transfer agreements, and data flow processes.
• Ensure data quality, security, integrity and regulatory compliance.

Skills

CDM leadership

Data management

Regulatory compliance

FDA & ICH knowledge

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences/CS or related field

Tools

EDC systems

MedDRA/WHODRUG coding

Job description

Summit Therapeutics, Inc. is seeking an Associate Director, Clinical Data Management to lead data management for global oncology trials.

You will direct CRF/eCRF design, database development, data validation, query resolution, and database lock, while coordinating with Biostatistics, Regulatory, and IT teams to ensure high-quality data. This senior role entails managing CDM staff and CROs, establishing standards, ensuring FDA/ICH compliance, and driving process improvements to deliver reliable