Crinetics Pharmaceuticals is dedicated to advancing treatments for rare endocrine diseases, aiming to enhance patients' lives by developing innovative therapies

Associate Manager, Clinical Monitoring

ManagerManagerFull TimeRemoteMid LevelCompany Site

Location

California

Posted

86 days ago

Salary

$115K - $144K / year

Seniority

Mid Level

Bachelor Degree5 yrs expEnglish

Job Description

• support global and regional clinical trial operations (CTO) • conduct and oversight of clinical site management and monitoring activities • implement strategy for in-house, regional monitoring activities applying a risk-based approach • lead monitoring activities on assigned studies • manage the CRA monitoring visit schedule for each assigned study • track and report to study team on compliance, trends and metrics related to monitoring and site management • manage or conduct monitoring oversight visits (MOVs)

Job Requirements

BS in biological sciences or related discipline
at least 5 years of experience working in the biotechnology/pharmaceutical industry
Monitoring experience in startup, execution and close out activities related to clinical studies
experience using risk-based monitoring processes strongly preferred
Previous experience as a Lead CRA, Trial Manager, or equivalent strongly preferred
An understanding and demonstrated application of Good Clinical Practices, ICH Guidelines and regulatory requirements
In-depth experience with cross functional drug development with prior regulatory inspection experience preferred
Excellent writing skills as they relate to the preparation of clinical trial documents

Benefits

discretionary annual target bonus
stock options
ESPP
401k match
top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
20 days of PTO
10 paid holidays
winter company shutdown