Crinetics Pharmaceuticals is hiring an Associate Manager, Centralized Monitoring to oversee and execute risk-based quality management (RBQM) activities for clinical trials. You will be responsible for proactive data surveillance, risk identification, and signal escalation to ensure study quality, participant safety, and compliance.
What You'll Do
- Execute centralized monitoring strategies aligned with Crinetics’ RBQM best practices.
- Perform ongoing centralized monitoring reviews using EDC, CTMS, safety, and vendor data sources.
- Identify emerging study-level and site-level risks through Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs).
- Evaluate trends, data anomalies, protocol deviations, and performance metrics to detect quality or compliance issues.
- Document and report signals, findings, and recommendations within designated systems.
- Support study teams in understanding the root causes of centralized monitoring findings.
- Contribute to development of RBQM documentation, including Centralized Monitoring Plans and KRI/QTL thresholds.
- Collaborate with Clinical Monitoring to align approaches with ICH-GCP E6 (R2/R3) and internal SOPs.
- Provide input on targeted monitoring actions, such as focused SDV or site follow-up.
- Support presentation of centralized monitoring strategies at study kick-off meetings.
- Evaluate the quality of data metrics and reports, providing input to improve efficiency and signal detection.
- Support oversight of centralized monitoring vendors, tools, or platforms.
- Participate in ongoing improvements to standardize technologies, systems, and processes for RBQM.
What We're Looking For
- Bachelor’s degree in life sciences, health sciences, or a related discipline.
- 5 years of clinical research experience, including centralized monitoring, RBQM, clinical data review, Clinical Operations, CRA, or Clinical Trial Management.
- Experience in all stages of drug development (start-up, maintenance, database lock) with a strong understanding of clinical trial processes and SDV/SDR strategies.
- A solid understanding and demonstrated application of Good Clinical Practices, ICH Guidelines, and regulatory requirements.
- Experience with clinical trial systems such as EDC, eTMF, IRT, and CTMS.
- Solid knowledge of RBQM methodologies in the clinical trial industry.
- Strong interpersonal skills with advanced oral/written communication and presentation abilities.
- Strong negotiation skills and a tactful approach to lead and influence cross-functional teams.
- Demonstrates critical thinking, problem solving with a focus on root cause analysis, and collaborative abilities.
- Proficiency in Microsoft Office tools.
Nice to Have
- Experience with RBQM technology is strongly preferred.
Technical Stack
- EDC, CTMS, eTMF, IRT, RBQM platform, Microsoft Office
Team & Environment
Supports cross-functional collaboration across multiple clinical studies.
Benefits & Compensation
- Compensation: $115,000 - $144,000 + equity (Stock options)
- Discretionary annual target bonus
- Stock options, ESPP
- 401k match
- Top-notch health insurance plans for employees and families (medical, dental, vision, basic life)
- 20 days of PTO
- 10 paid holidays
- Winter company shutdown
Work Mode
This is an onsite position.
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
