Clinical Study Lead (Sr. Clinical Research Associate)
Salary : $120-130K
Candidates should take the time to read all the elements of this job advert carefully Please make your application promptly.
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!
J-18808-Ljbffr
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