Senior Manager, Clinical Data Management
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 .
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 the scope of the role and business needs.
Minimum Qualifications:
- Bachelor’s degree in clinical, biological, mathematical, or a related scientific field, or an equivalent combination of relevant education and experience.
- 6-8 of clinical data management experience in the biotechnology, pharmaceutical, or clinical research industry.
- Experience independently leading clinical data management across multiple studies or a complex clinical program through major lifecycle milestones.
Preferred Qualifications:
- Extensive experience with electronic data capture systems, including database development and oversight, user acceptance testing, data review, query management, complex amendments or migrations, and database lock activities.
- Experience providing comprehensive oversight of clinical data management work performed by CROs or other external service providers, including scope, quality, timelines, resources, and risk management.
- Working knowledge of clinical drug development, ICH, Good Clinical Practice, and applicable clinical data management requirements.
- Demonstrated ability to resolve complex data and operational issues, manage competing priorities and resources, influence cross-functional stakeholders, and communicate recommendations to senior leaders.
- Experience supporting oncology clinical trials.
- Experience with Medidata Rave or a comparable electronic data capture platform.
- Experience with database migrations, significant database amendments, or integrated clinical systems.
- Experience with IRT development or IRT-to-EDC integrations.
- Experience preparing data for regulatory submissions or health-authority interactions.
- Experience leading clinical data management procedures, standards, inspection readiness, audits, or corrective actions.
- Advanced degree in a relevant field.
How You Will Work:
- Demonstrates collaboration and teamwork. Works well with others and understands that collaboration leads to better results.
- Possesses strong communication skills. Communicates clearly, concisely, and professionally. Listens actively to build understanding.
- Exhibits strong interpersonal skills and self-awareness. Builds and cultivates strong and enduring relationships with others. Acts with humility and understands own strengths and weaknesses.
- Shows continuous improvement and a commitment to self-management and development. Operates with a continuous improvement mindset and continuously seeks to expand own knowledge and capabilities.
- Demonstrates a patient focus. Puts the patient first in actions and decisions taken.
Compensation, Benefits, and So Much More
- The expected salary range for this role based on the primary location for this position in California is $175,000 - $205,000 per year. Offer amounts are determined by factors such as experience, qualifications, geographic location, and other job-related factors permitted by law.
- A great environment where we work collaboratively, leverage each other’s strengths, and work toward a shared vision with our common goals of doing the best thing for patients.
- A robust and enduring approach to your development and career growth fueled by a strong learning curriculum and career guidance that helps you understand how you can grow your career at CytomX.
- A robust and highly competitive total rewards program that helps you achieve your compensation goals while supporting a great work / life balance.
Conditions of Employment
- Background investigations are required for all positions at CytomX, consistent with applicable law.
CytomX’s Commitment to Diversity, Equity, Inclusion, and Belonging (DEIB)
CytomX believes that DEIB helps drive our success, and we encourage candidates from all identities, backgrounds, and abilities to apply. We are an equal opportunity employer committed to building an inclusive, innovative work environment with employees who reflect our values and ultimately, serve our patients. Therefore, in all aspects of the employment process, we provide employment opportunities to all qualified applicants without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity or expression, pregnancy, medical condition related to pregnancy, creed, ancestry, national origin, marital status, genetic information, or military status, or any other protected status in accordance with applicable law.
Further, we are committed to the full inclusion of all qualified individuals. As part of this commitment, we (and the agencies we work with) will assist individuals who have a disability with any reasonable accommodation requests related to employment, including completing the application process, interviewing, completing any pre-employment testing, participating in the employee selection process, and/or to perform essential job functions where the requested accommodation does not impose an undue hardship. If you have a disability and require reasonable accommodation, or need other assistance in applying for or interviewing for this position, please direct your inquiries to Human Resources, at hr@cytomx.com
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