Clinical Trial Operations Specialist

1 week ago

Seattle, Washington, United States Lifelancer Full time
About the Role

We are seeking a highly motivated and experienced Clinical Trial Manager to oversee the execution of clinical trial site set-up, management, and closure for one or more clinical trials. The successful candidate will be responsible for the successful completion of study activities at assigned clinical trial sites.

This is a unique opportunity to join our team as we prepare for clinical trials in the U.S. and expand our operations globally. As a Clinical Trial Manager, you will play a critical role in driving the success of our clinical trials and contributing to the development of life-changing regenerative therapies.

Key Responsibilities:

  • Participate in all aspects of clinical trial operations, including protocol development, consent form creation, case report form design, study planning, safety reviews, and regulatory document preparation.
  • Drive start-up, conduct, and close-out activities at assigned clinical trial sites.
  • Select and train qualified investigators and clinical trial sites.
  • Review monitoring reports and follow-up letters.
  • Conduct risk assessments, develop mitigation strategies, and create contingency plans for assigned clinical trial sites.
  • Oversee budgets and invoicing for assigned clinical trial sites.
  • Develop and manage timelines and metrics for assigned clinical trial sites.
  • Provide feedback to the clinical project management team regarding vendor-related activities impacting clinical trial sites.
  • Communicate with internal teams to proactively identify challenges at assigned clinical trial sites and collaborate on strategies to mitigate/resolve.
  • Ensure adherence to applicable regulations, recognized guidelines, clinical trial protocols, and standards of clinical practice at assigned clinical trial sites.

About Our Company

Aurion Biotech is a clinical-stage biotech company dedicated to restoring vision to millions of patients worldwide through regenerative therapies. With offices in Seattle, Boston, and Tokyo, we have received prestigious awards and recognition for our innovative approach. We are committed to making a positive impact on people's lives and strive to deliver exceptional results in an exciting and dynamic environment.

Benefits

  • Competitive salary: $121,873 per annum (midpoint of the range)
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment
  • Comprehensive benefits package, including health insurance, 401(k) matching, EAP, FSA, and generous PTO
  • Total rewards, including competitive equity grants, salaries, and bonuses
  • Perks and fun, including paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects

Requirements

  • Bachelor's degree in a health profession, science, or engineering field
  • A minimum of 5 years of experience in a medical device, biotechnology, pharmaceutical company, CRO, or clinical trial site
  • Some monitoring experience preferred
  • Previous study coordinating or management experience preferred
  • Excellent written and oral communication skills
  • Computer literacy and proficiency in MS Office, Excel, PowerPoint, etc.
  • Excellent organizational skills and attention to detail
  • Ability to apply knowledge of GCP and applicable regulations and guidances appropriately

Lifelancer Platform

Lifelancer is a talent-hiring platform connecting professionals with opportunities in Life Sciences, Pharma, and IT. For more details about this role and similar positions, please visit our website.

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