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

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  • EPM Scientific
  • San Francisco, CA

Job Description

Job DescriptionJob 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!
Company DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.
Job Responsibilities:
•\tConducting Post Market Activities and Post Market Surveillance
•\tManaging Customer and Product Complaint Investigation programs
Education and Experience:
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry
•\tBachelor's degree
•\tComputer proficiencyCompany DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r\nJob Responsibilities:\r\n•\tConducting Post Market Activities and Post Market Surveillance\r\n•\tManaging Customer and Product Complaint Investigation programs\r\nEducation and Experience:\r\n•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r\n•\tBachelor's degree\r\n•\tComputer proficiency

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