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Study Start Up Specialist

EPM Scientific
San Francisco, CA Full Time
POSTED ON 1/19/2025
AVAILABLE BEFORE 4/18/2025

Salary : $85-95K

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Company Summary : A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Study Start Up Specialist 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, and are building out their clinical team to support a large Ph. III study.

  • Candidate must be based in SF Bay Area to be considered.

The Study Start Up Specialist will be responsible for :

  • Conducting site start-up activities and timely initiation of sites for clinical trials (1-2x per quarter)
  • Feasibility assessments / visit evaluations for clinical and post-authorization studies, as required
  • Supporting site management activities : investigating, following up on, and escalating site issues as needed.
  • Assisting with pharmacovigilance, safety reporting management, and investigations of quality complaints.
  • In-house / on-site document quality management (including, but not limited to, trial master file and investigator site file).
  • An ideal candidate for this role MUST have…

  • Graduate qualifications in Biological Sciences, Nursing, Pharmacy, or related discipline
  • At least 1 year of experience as a Clinical Research Assistant or higher
  • Working knowledge of ICH GCP guidelines
  • Proven experience in supporting clinical trials / projects
  • 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 Study Start Up Specialist role, don't hesitate to reach out!

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    Salary : $85,000 - $95,000

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