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Clinical Trials Management Associate I/II/Senior

Cascadian Therapeutics is a clinical-stage biopharmaceutical company specializing in developing innovative therapeutic product candidates for the treatment of cancer. Our goal is to discover, develop and commercialize novel compounds that have the potential to improve the lives and outcomes of cancer patients. Our most advanced product candidate is tucatinib (ONT-380), an orally active and selective small molecule HER2 inhibitor. We are headquartered in Seattle, Washington. For more information, visit www.cascadianrx.com.

Summary:

The Clinical Trials Management Associate (CTMA) assists with overseeing operational aspects of clinical research studies. Responsibilities include assisting with vendor oversight, monitoring at select sites, and other logistic operations as required.

Key Job Responsibilities:

  • Assists with assigned aspects of clinical studies to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
  • Assists in the activities of planning, implementing, monitoring and managing at select clinical sites.
  • May assist with tasks related to vendor management.
  • May create and maintain various study status tracking tools.
  • Maintains contact with clinical investigators and staff to ensure compliance with protocols and overall clinical objectives.
  • May participate in the design and development of clinical trial protocols and case report forms and other clinical trial documents.
  • May assist in the preparation of clinical study reports and annual reports.
  • Oversees drug accountability at investigator sites.
  • Works with data management to resolve data discrepancies.
  • Performs other responsibilities as assigned.

Education / Experience / Professional Requirements:

  • Bachelor's degree in a scientific discipline or health-related field (or equivalent).
  • Minimum of 1-2 years of relevant clinical experience in the pharmaceutical or healthcare industry is required. Experience in oncology preferred. Monitoring experience is preferred but not required.
  • Knowledge of FDA regulatory requirements and ICH/GCP guidelines preferred.
  • Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines, with background in oncology preferred.
  • Computer proficiency (PC-Windows preferred) and proficiency in Microsoft Word, Excel, PowerPoint, and Sharepoint.
  • Clear and concise verbal and written communication skills.
  • Detail oriented with strong organizational skills.
  • Ability to prioritize and handle multiple tasks and projects simultaneously in a fast-paced environment.
  • Ability to work independently and in a highly collaborative team environment.
  • Dedication to quality and reliability in all work tasks.
  • Self-motivated, eagerness to grow professionally and commitment to self-development.
  • Requires an ability and willingness to travel (up to 30%) as necessary, consistent with the project needs.

Cascadian Therapeutics offers a comprehensive and highly competitive benefits package including medical, dental, vision care, life insurance, short and long term disability, stock options, ESPP, a matching traditional and ROTH 401(k) plan, and fully subsidized transit pass/parking.

If you are interested in working with our team in a collaborative and professional work environment, please Submit Resume ».

We are an Equal Opportunity Employer