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Job

Clinical Trial Manager - Cell Therapy

  • Location

    San Francisco Bay Area

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Emily Mato

  • Contact email:

    e.mato@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    8 months ago

  • Expiry date:

    2020-12-24

  • Startdate:

    ASAP

CLINICAL TRIAL MANAGER (CTM)

SCOPE

Exciting opportunity to join a growing team working in the cell therapy space. If you are at all interested in continuing your career in biologics, this is your opportunity to join a note-worthy company with cutting edge science. As a Clinical Trial Manager, you will oversee all aspects of study initiation, implementation and progress.

RESPONSIBILITIES

  • Monitor study progress and provide regular updates to senior management and stakeholders
  • Contribute to developing, implementing and updating SOPs, study protocols, laboratory manuals and other study-related documents
  • Coordinate and provide site and CRA training to ensure protocols are implemented and followed in accordance with SOPs and industry regulations
  • Manage CRO and other study vendors, including developing and revising service agreements, budgets and timelines and reviewing and approving expenses
  • Develop monitoring plans and guidelines and co-monitor visits as needed
  • Ensure clinical sites have all necessary supplies and documentation
  • Perform regular reviews and quality check data and documents uploaded to the trial master file
  • Identify, report and resolve issues within clinical operations study team

EDUCATION/EXPERIENCE

  • Bachelors degree in life sciences or equivalent required
  • Advanced degree in life sciences preferred
  • 3+ years clinical trial management experience required
  • Previous cell therapy or biologics experience required
  • Demonstrated knowledge of industry regulatory requirements, including ICH/GCP and clinical trial operations guidelines

SKILLS:

  • Excellent verbal and written communication skills
  • Strong management skills and demonstrated team-building skills
  • Ability to work in fast-paced environments within strict timelines

My team and I are working on a number of additional opportunities for a broad portfolio of clients across the US and internationally. If this role isn't for you but you would like to explore your options in the market, I would welcome a confidential conversation at your convenience. Please contact me at (619) 350-6149 or e.mato@hamlynwilliams.com