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Seagen

Clinical Trial Manager

Development - Madrid, Spain

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 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.

Responsibilities:

  • Act as Global or Regional Protocol Lead. Serve as main point of contact for clinical site management.
  • May have dotted line oversight of Functional Service Provider resources.
  • May act as mentor for less senior RCTO staff on the study.
  • Participate as the main point of contact for RCTO on the Clinical Study Team.
  • Supports Molecule Lead. Closely collaborates with internal study team members, Contract Research. Organizations, vendors or sites.
  • Monitors metrics to drive on-time delivery of clinical trial milestones. Assist with creation and review of protocols/ICFs and clinical trial documents.
  • Lead in identification, evaluation, and selection of clinical trial sites.
  • Coordinate and manage vendor processes. May contribute to vendor selection.
  • Facilitate communication between sites and Seagen cross-functional staff.
  • Lead functional teams within RCTO. Conduct data review.
  • Accountable for completeness of Trial Master File.
  • Support audit and/or inspection activities.
  • Primary point of contact for CRO activities.
  • May lead process improvement initiatives and departmental projects.
  • Performs all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, and other applicable guidelines.

Qualifications:

  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 6 years of relevant clinical trial management experience.
  • Ability and willingness to travel.
  • Proficiency in CFR and GCP/ICH requirements, as well as European Clinical Trial Directive.
  • 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.
  • Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF).
  • Global Phase I-III trial Management experience (preferred).
  • CRO management (preferred) Oncology clinical research experience (preferred).
  • Experience managing large teams (direct or dotted line reporting) (preferred).

As a leading employer in our industry, 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. To learn more about Seagen, please visit www.Seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.

Apply:


Seagen

Seagen is an Equal Opportunity Employer

Submitted: 04/22/2022

Lundbeck Seattle BioPharmaceuticals Lundbeck -- tirelessly dedicated to restoring brain health.




















 
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