Manager Clinical Data Programming

DevelopmentRemote, Bothell, United States


Description

Position at Seagen

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! 

Summary: 

The Manager, Clinical Data Programming will oversee Clinical Data Programming within Clinical Data Management and will ensure that product and study level deliverables are completed on time, with a high degree of quality, and in accordance with corporate and regulatory requirements. This position will also be responsible for managing salaried and contract CDPs.  

Principal Responsibilities: 

  • Manage CDPs efficiently across studies by setting goals and providing oversight, guidance, mentoring, feedback and performance reviews. Perform hiring and training activities as needed 
  • 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) 
  • Develop and guide team members through the development of DM documents including program specifications 
  • DM Project Management: Understands critical tasks and milestones; ensures data management deliverables are met per study timelines 
  • 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 
  • Research, evaluate, and direct departmental initiatives and new technologies/innovations to improve CDM processes; represent CDP through working groups (internal and external) and initiatives where thorough knowledge of CDP practices/processes are required 
  • Align with and support management and corporate objectives 
  • Support of implementation of data standards 
  • Perform study resourcing and budget support as appropriate 
  • 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 
  • Encourage collaboration through relationship building with other leaders; ability to influence without authority   

Qualifications: 

  • Minimum of 10 years of relevant experience 
  • Requires 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 
  • SAS programming experience 
  • Strong experience and knowledge in the application of data standard 
  • 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   

Preferred: 

  • Previous experience with RTSM/IWRS and ePRO systems 
  • Previous experience working on oncology trials 
  • Previous experience managing, tracking, and reconciling IRF data 
  • Previous management experience   

Education: 

  • BA/BS in relevant field   

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.  

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.  

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law. 

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