DescriptionHeadquarters 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
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.
