Hybrid Senior Manager, Clinical Data Management

CytomX Therapeutics, Inc.; Emeryville (CA); Hybrid; USD 175,000 - 205,000; Full time

Job summary

CytomX Therapeutics, Inc. seeks a senior clinical data management leader to oversee data across a portfolio of studies, ensuring data accuracy, completeness, and timely availability for critical decisions.

You will partner with study teams and CROs from startup to database lock, lead complex database changes and migrations, establish integrated data-management plans, and deliver high-quality data packages for regulatory submissions and governance reviews.

Qualifications

• Bachelor’s degree in clinical, biological, mathematical, or related field.
• 6–8 years of clinical data management experience in biotech/pharma.
• Experience leading CDM across multiple studies.

Responsibilities

• Provide senior-level clinical data management leadership across a portfolio of assigned studies or a complex clinical program from study startup through database lock and study closure.
• Provide strategic and operational oversight of contract data management providers, including scope, deliverables, quality, timelines, resources, risks, and issue resolution.
• Lead the development, review, and approval of case report forms, CRF completion guidelines, edit-check specifications, data-transfer specifications, report specifications, and other study-specific data management documentation.
• Direct the development, testing, maintenance, and modification of clinical study databases and associated system integrations, including complex amendments and migrations.
• Establish the user acceptance testing approach and lead cross-functional testing of clinical databases and integrations.
• Represent Clinical Data Management in protocol development, integrated study planning, risk assessment, project timelines, and other relevant study or program documents.
• Define and oversee risk-based data-review strategies to identify errors, trends, discrepancies, and incomplete data in a timely manner.
• Lead cross-functional resolution of significant data-quality, reconciliation, and operational issues with sites, vendors, and internal stakeholders.
• Accountable for the preparation and delivery of high-quality clinical data packages for study-team and governance reviews, safety evaluations, regulatory deliverables, publications, and other approved uses.
• Independently analyze complex study and operational issues, determine or recommend solutions, and elevate significant program, compliance, resource, or business risks as appropriate.
• Distill and communicate complex study status, data-quality findings, risks, dependencies, and recommendations to functional leadership, cross-functional partners, and senior stakeholders.
• Lead complex database amendments, migrations, and upgrades in accordance with approved study requirements and change-control processes.
• Perform other responsibilities consistent with the scope of the role and business needs.

Skills

Leadership

CDM oversight

ICH/GCP knowledge

Communication skills

Education

Bachelor’s degree in clinical/biological/scientific field

Advanced degree preferred

Tools

Medidata Rave

EDC systems

Job description

CytomX Therapeutics, Inc. seeks a senior clinical data management leader to oversee data across a portfolio of studies, ensuring data accuracy, completeness, and timely availability for critical decisions.

You will partner with study teams and CROs from startup to database lock, lead complex database changes and migrations, establish integrated data-management plans, and deliver high-quality data packages for regulatory submissions and governance reviews.