Senior Manager, Clinical Data Management at CytomX Therapeutics in Emeryville, CA

Job description

Headquarters Location: Emeryville, CA Candidate Location: Hybrid Travel Required: 10% Reports To: Executive Director, Clinical Data Management Department: Clinical Data Management Position Type: Full-time, Exempt About CytomX Therapeutics: CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel PROBODY® therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes, and holding each other to the highest possible standards. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engagers, and immune modulators such as cytokines. CytomX’s clinical-stage pipeline includes CX-2051 and CX-801. Learn more at www.cytomX.com . Who You Are and What You’ll Do: You are passionate about life sciences and making a difference to cancer patients, their families, and healthcare providers. You will provide senior-level leadership for clinical data management across a portfolio of assigned studies or a complex program, helping ensure that clinical trial data are accurate, complete, and available to support study objectives and informed decision-making. You will partner with internal study teams and external data management providers from study startup through study closure. Near-term responsibilities may include leading complex database changes or migrations, establishing integrated data-management plans, overseeing data review and vendor execution, and delivering timely, high-quality clinical data packages for key development decisions. Job 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 escalate 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