Clinical Trial Manager

Found in: Appcast Linkedin GBL C2 - 2 weeks ago


Bothell, United States Medix™ Full time

The Clinical Trial Manager holds responsibility for overseeing the implementation of ongoing clinical trials, ensuring compliance with relevant quality standards such as ICH-GCP Guidelines, SOPs, and applicable regulations.


Key Roles and Responsibilities:

  • Lead the overall execution of one or more clinical trials, including oversight of setup, ongoing quality assessment, and final reconciliation of study documents.
  • Review site regulatory documents/packages for Sponsor oversight of CRO and site activities.
  • Ensure collection, inventorying, and filing of study regulatory files align with ICH GCP and sponsor requirements.
  • Assist in preparing and following up on in-house and on-site quality audits, as well as regulatory authority inspections.
  • Develop specifications for outsourcing to vendors, reviewing vendor proposals, contracts, and budgets for accuracy.
  • Oversee clinical monitoring and other vendor activities to ensure integrity, accuracy, and accountability of trial activities and data.
  • Coordinate with CRO and data management for database cleaning and final database lock.
  • Collaborate with the CMC team regarding investigational product supply and any on-site IP issues during the trial.
  • Partner with consultants for review and advice on clinical and laboratory matters.
  • Contribute to the development of abstracts, presentations, manuscripts, and other external communication materials.
  • Perform other assigned activities as required.


Preferred Education/Experience:

  • Bachelor of Science degree or equivalent, preferably in Life Sciences.
  • Minimum of 6 (7 years for Senior CTM) years of clinical trial experience, with at least 1-2 years managing clinical trial activities.
  • Senior CTM requires experience managing a CRO and a complex study in a previous Clinical Trial Manager or Clinical Project/Program Manager position.
  • Experience in set-up and management of third-party vendors, as well as study start-ups.
  • Experience with phases I & II clinical trials; phase III & global trial experience are advantageous.


Knowledge, Skills, and Abilities:

  • Strong knowledge of FDA, CFR, and ICH GCP requirements, along with other regulatory standards.
  • Excellent leadership and management skills to provide planning, coordination, and direction.
  • Outcome-driven with the ability to thrive in a fast-paced environment and effectively manage pressure.
  • Proficiency in setting up and tracking key metrics and motivating a study team.
  • Proven interpersonal skills with the ability to build strong relationships cross-functionally.
  • Proficiency with MS Office products and electronic systems.
  • Flexibility in work hours to accommodate international collaborations and travel requirements.



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