Clinical Study Lead; Sr. Clinical Research Associate

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 for a large global Phase 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 clinical operations 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!