Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!
The Principal Clinical Data Associate – Data Surveillance, will lead clinical data surveillance activities across the portfolio with minimal support and oversight. This role will also provide input into data surveillance strategies and application of new technologies to gain insight into clinical data.
- Reviews and understands risks related to study execution and compliance (critical data and processes, safety, and data quality)
- Reviews output of dashboards and provides actionable follow up to study teams including adjustments to Source Data Verification (SDV) activities, focused data review, recommendations for site training, etc.
- Recognizes signals and trends and assists study teams in investigation, root cause analysis, and follow-up
- Fosters effective cross-functional communication with study teams and other internal and external stakeholders
- Conducts training with study teams on dashboard implementation, navigation, and processes supporting Data Surveillance
- Provides input and feedback for analytics and dashboard enhancements/new features
- Implements Seagen strategies, initiatives, processes, and standards to support timelines and deliverables for quality data
- Aligns with protocol, ICH GCP, and regulatory requirements
- Provides and maintains documentation to support activities
- Minimum of a bachelors’ degree in Science or Health Care
- Minimum 5 years’ experience in the Biotech, Pharmaceutical, or Healthcare Industry in Clinical Operations, Clinical Development, Clinical Data Management
- Experience with Data Visualization tools (Power BI preferred)
- Knowledge of Risk-Based Quality Management (RBQM) or Risk-Based Monitoring (RBM) methodologies
- Skilled in assessing data trends and patterns, identifying outliers and potential signals, and managing follow-through
- Thorough understanding of clinical development process and principles of study design
- Strong project management expertise as well as effective verbal and written communication skills
- Ability to work independently, organize tasks, time and priorities, ability to multi-task
- Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally
- Knowledge of Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements
- Technical expertise in database development, data management, etc. and associated principles including CRF design, database set up, data review, and data cleaning activities
- Knowledge of basic statistical principles
- Desire to explore and evaluate new technology applications such as AI, Machine Learning, and predictive analytics
As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.
The hiring pay range for this position is $119,000 to $154,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.