Supervisor Clinical Trials

Clinical Development Operations Bothell, Washington


Description

Summary:  

Responsible for line-management activities for assigned Seattle Genetics staff, including Clinical Trials Associates (CTAs).  The position focuses on the coordination of activities required to recruit, train, develop and retain assigned direct reports. Position requires ability to contribute to study-related work at the level of CRA I or above. Position will serve as key contributor to clinical systems process integrations, development, and improvement as well as quality initiatives. Position will support day to day operational activities of the CTA Team. 
 
Responsibilities: 

  •  Recruit, train, develop, supervise and retain assigned team 
  • Screen new contract and FTE candidates, arrange interview teams and debriefings, make hiring decisions 
  • Contribute to team curriculum and onboarding plan maintenance and improvement 
  • Coach, mentor, and advocate for direct reports in job responsibilities, company culture, and career goals 
  • Identify training needs, formulate strategies to address training gaps, and conduct training 
  • Evaluate ongoing performance and perform performance reviews of assigned staff 
  • Assess the quality of assigned staff's clinical work through regular review and evaluation of work product including conducting quality control checks within clinical systems, including CTMS, and the eTMF/TMF 
  • Identify and escalate quality risks and issues, contributing to plans to prevent or correct deficiencies in performance of staff 
  • Develop and maintain effective relationships with study and management teams as well as the cross-functional relationships with which CTAs interact to optimize feedback 
  • Contribute to planning of resource allocations to clinical studies and other Clinical Development Operations activities 
  • Contribute to Clinical Development Operations quality, systems, and process initiatives 
  • Support day to day operational activities of the team in partnership with other line-managers and Team Manager(s) 
  • Serve as CRA I or above on assigned studies 
  • Contribute to preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as regulatory authority inspections 
  • Perform all duties and responsibilities in accordance with CFR, GCP/ICH and other applicable guidelines 
  • Adhere to Clinical Development Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable 
  • Work on problems of diverse scope where analysis of situations or data requires evaluation of identifiable factors.  Exercise judgment within generally defined procedures and policies in selecting methods and techniques for obtaining solutions 
  • Normally receives no instruction on routine work, general instruction on new assignments.  Should be demonstrating increased skill and independent action 

 Qualifications: 

  • A minimum of 4+ years of relevant pharmaceutical industry or clinical trial experience, including 1-2 years as a CTA, preferred 
  • Qualify as CRA I or above (see CRA I or above job description) 
  • 1-2 years supervisory experience preferred 
  • Proficient with Microsoft Office software 
  • Knowledge of CFR and GCP/ICH requirements 
  • Demonstrated ability to successfully contribute as a member of a project team 
  • Demonstrated ability to successfully manage multiple competing priorities 
  • Excellent planning and organizational skills 
  • Effective written and verbal communication and presentation skills 
  • Demonstrated ability to lead by example and to encourage team members to seek solutions 
  • Proven interpersonal skills, including strong mentoring, and motivational skills 

Education: 

  • Bachelor’s degree or equivalent or relevant and qualifying training/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. 

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