Senior Clinical Trial Manager (Remote)

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 Sr. Clinical Trial Manager is the Regional or Global Protocol Lead in Regional Clinical Trial Operations (RCTO) responsible for the coordination of clinical operations required to initiate, execute and complete clinical trials to drive on-time delivery of clinical trial milestones.  May act as people manager to more junior staff. 
 
Principal Responsibilities: 

  • Acts as Global Protocol Lead (or Molecule Lead for smaller programs). Serve as main point of contact for clinical site management 
  • May manage more junior staff. Dotted line oversight of Functional Service Provider resources 
  • May act as mentor for less senior RCTO staff on the study 
  • Supports Molecule Lead. Collaborates with internal team members, Contract Research Organizations, vendors and sites 
  • Is the RCTO representative on the Clinical Study Team 
  • Assists with design and review of protocols/ICFs and other study documents 
  • Leads in identification, evaluation, and selection of clinical trial sites 
  • Coordinates and manages vendor processes 
  • Accountable for tracking of ancillary and investigational supplies, specimens and/or imaging 
  • Facilitates communication between sites and Seagen cross-functional staff 
  • Leads functional teams within Regional Clinical Trial Operations 
  • Conducts data review 
  • Accountable for completeness of Trial Master File 
  • Work closely with quality function to ensure inspection readiness. Support audit and/or inspection activities 
  • Primary point of contact for CRO activities 
  • Ensures training compliance of all staff 
  • Contributes to process improvement initiatives and departmental projects 
  • Performs all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, and other applicable guidelines 
  • Must demonstrate high-level leadership skills and proactive communication. Ability to build, engage and energize the team and set high performance expectations 
  • Ability to work successfully in an entrepreneurial and fast-moving environment 

Required Qualifications: 

  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 8 years of relevant clinical trial management experience 
  • Ability and willingness to travel  
  • Global Phase I-III trial Management experience 
  • CRO management experience 
  • Thorough knowledge of CFR and GCP/ICH requirements as well as European Clinical Trial Directive 
  • Experience managing large teams (direct or dotted line reporting) 
  • Excellent leadership, communication, and organizational skills 
  • Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems simultaneously 
  • Strong communication and inter-personal skills 
  • Highly responsive and proactive, a team player 
  • Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (eg, CTMS, EDC and eTMF) 

Preferred Qualifications: 

  • Oncology clinical research experience 

 

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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