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 Sr. Manager, Clinical Data Management oversees Data Management activities for Phase I-IV studies and ensures that product and study level deliverables are completed on time, with a high degree of quality, and in accordance with corporate and regulatory requirements. The Senior Manager, Clinical Data Management has expert knowledge of FDA regulations and general industry standards and drives departmental infrastructure development. This position will also be responsible for managing salaried and contract CDAs.
- Manage CDAs efficiently across studies by setting goals and providing oversight, guidance, mentoring, feedback and performance reviews. Perform hiring and training activities as needed
- Lead studies and guide team through DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials
- Develop and guide team members through the development of DM documents including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans
- Independently perform and guide study team members (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs,
- Clinical Pharmacologists, Biomarker/Bioinformatics scientists, Medical Writers, Regulatory representatives, etc.) through the data cleaning and database lock process in an efficient and timely manner
- DM Project Management: Understand critical tasks and milestones; ensure data management deliverables are met per study timelines
- Research, evaluate, and direct departmental initiatives and new technologies/innovations to improve CDM processes; represent CDM through working groups (internal and external) and initiatives where thorough knowledge of CDM practices/processes are required
- Align with and support management and corporate objectives
- Support implementation of data standards
- Drive and guide complex process and initiatives
- Communicate and message information to multiple levels of leadership appropriately, applying appropriate level of detail to audience to ensure efficient utilization of resource
- Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product. Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits)
- Encourage collaboration through relationship building with other leaders; demonstrate ability to influence without authority
- May program SAS Non-System Edit Checks (NSECs) and/or SAS Data Listings. Run SAS programs, review SAS logs, and generate output. Mentor less proficient SAS users as appropriate
- Perform study resourcing and budget support as appropriate.
- Minimum of 6 years of relevant experience including prior supervisory experience
- Effective organizational and communication skills
- Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession
- Detail oriented; performs quality and accurate work
- Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process
- Previous relevant EDC experience
- Strong experience and knowledge in the application of data standards
- Excellent supervisory, problem solving, negotiation and organizational skills
- Knowledge and understanding of non–CRF data flow, transfer, and integration
- Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials
- Exhibits composure and strong conflict management skills
- Prior experience managing vendors/CROs
- Previous experience with RTSM/IWRS and ePRO systems
- SAS programming experience
- Previous experience working on oncology trials
- Previous experience managing, tracking, and reconciling BICR/IRF data
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 $142,000 to $184,000 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.