Clinical Study Lead (Sr. Clinical Research Associate) Job at EPM Scientific - Phaidon International, San Francisco, CA

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  • EPM Scientific - Phaidon International
  • San Francisco, CA

Job Description

Salary: $120-130K

Company Summary: A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Clinical Study Lead for a hybrid role in San Francisco (Palo Alto). Their commercial supply of pharmaceutical products generated $83m in revenue in FY2023 (a 24% uptick from the year prior during a year of record layoffs). Since their first clinical trials in 2006, they've had 3 approvals already on the market. Currently, they have 6 indications in Phases II and III, so they are looking for a driven, growth-oriented Clinical Study Lead to drive their pipeline forward.

***** Candidate must be based in SF to be considered.*****

The Clinical Study Lead will be responsible for:

  • Leading in house study activities studies for a large global Ph. 3 study
  • Mentoring junior team members
  • Overseeing the set-up and maintenance of study systems which may include Clinical Trial Management System (CTMS), Trial Master File (TMF), study SharePoint etc.
  • Reporting into the Clinical Program Lead
  • May be responsible for CRA and CTAs as direct reports

An ideal candidate for this role MUST have…

  • 5+ years of sponsor/CRO experience
  • 3+ years of ON-SITE monitoring experience
  • 2+ years of experience leading studies or trials in house (rare disease or derm preferred)
  • At least 2 years of experience managing direct reports or mentoring junior clin ops team members
  • A Bachelor's degree in Biological Sciences, Nursing, Pharmacy or a related discipline
  • A working knowledge of ICH GCP guidelines

Benefits:

  • Competitive salary with benefits
  • High degree of commercial exposure early in your career
  • Being a part of team whose work directly aims to improve the quality of people's lives
  • Great work-life balance

If you are interested in this Clinical Study Lead role, don't hesitate to reach out!

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