Seagen

Associate Clinical Trial Manager

Development - London, United Kingdom

Description

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 Associate Clinical Trial Manager is the Regional Clinical Trial Operations individual 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 in support or lead role.

Principal Responsibilities:

• May act as study lead and participate on the cross-functional study team.
• May act as mentor for less senior RCTO staff on the study.
• Create and maintain clinical trial documents.
• Participate in the identification, evaluation, and selection of clinical trial sites.
• Conduct data review.
• Responsible for tracking of ancillary and investigational supplies, specimens and/or imaging.
• Support CTMS and Trial Master File completeness.
• Support audit and/or inspection activities.
• May manage CRO activities.
• Support Clinical Trial
• Manager(s). Collaborates with internal team members, Contract Research Organizations, vendors and sites.
• Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Perform all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, and other applicable guidelines.
• May contribute to process improvement initiatives and departmental projects.

Qualifications:

• BA/BS or equivalent or any relevant and qualifying training with a minimum of 5 years of relevant clinical trial management experience.
• Ability and willingness to travel Excellent leadership, communication, and organizational skills. Able to multi-task under limited direction and on own initiative.
• 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.
• Knowledge of CFR and GCP/ICH requirements.
• Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF)
• Global Clinical Trial Management experience (preferred).
• Oncology clinical research experience (preferred).

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 04/22/2022