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Senior Clinical Study Manager

2 months ago

San Francisco, California, United States EPM Scientific - Phaidon International Full time

Salary: $140-160K

Company Overview: EPM Scientific - Phaidon International is a renowned global specialty pharmaceutical organization with a strong history of success. We are currently seeking a dedicated Clinical Study Lead for a hybrid position in San Francisco (Palo Alto). Our pharmaceutical product line achieved $83 million in revenue in the last fiscal year, marking a 24% increase from the previous year. Since initiating our first clinical trials in 2006, we have successfully brought three products to market and currently have six indications in advanced Phases II and III. We are in search of a proactive and growth-focused Clinical Study Lead to propel our pipeline forward.

***** Candidates must be located in San Francisco to be considered. *****

The Clinical Study Lead will be accountable for:

  • Managing studies within the Vitiligo program in-house
  • Leading a cross-functional team to ensure effective study delivery and oversight for the assigned project
  • Overseeing the establishment and upkeep of study systems, which may include Clinical Trial Management System (CTMS), Trial Master File (TMF), and study SharePoint
  • Possibly supervising Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs) as direct reports
  • Reporting to the Clinical Program Lead

The ideal candidate for this position MUST possess...

  • A minimum of 5 years of experience in a sponsor role
  • At least 2 years of experience managing studies or trials in-house (experience in rare diseases or dermatology preferred)
  • A minimum of 2 years of experience in managing direct reports or mentoring junior clinical operations team members
  • A Bachelor's degree in Biological Sciences, Nursing, Pharmacy, or a related field
  • A solid understanding of ICH GCP guidelines

Benefits:

  • Competitive salary accompanied by comprehensive benefits
  • Significant commercial exposure early in your career
  • Being part of a team dedicated to enhancing the quality of life for individuals
  • Excellent work-life balance

If you are interested in the Clinical Study Lead position, please reach out for more information.