Crinetics Pharmaceuticals
Discovering drugs for endocrine diseases and endocrine-related tumors. #acromegaly #crinetics #CarcinoidSyndrome
Associate Manager, Centralized Monitoring
Location
United States
Posted
5 days ago
Salary
$115K - $144K / year
Bachelor Degree5 yrs expEnglishGoogle Cloud Platform
Job Description
• Execute and oversee centralized monitoring activities across clinical trials using a risk-based quality management (RBQM) framework
• Perform ongoing centralized monitoring reviews using clinical, operational, and quality data sources
• Identify emerging study-level and site-level risks through Key Risk Indicators (KRIs)
• Support the evaluation of trends, data anomalies, and protocol deviations
• Document and report signals, findings, and recommendations within designated systems
• Collaborate with Clinical Monitoring to support alignment of monitoring approaches with ICH-GCP E6 (R2/R3) and internal SOPs
• Support oversight of centralized monitoring vendors, tools, or platforms
• Participate in ongoing improvements in standardizing technologies, systems, processes, and training materials
Job Requirements
- Bachelor’s degree in life sciences, health sciences, or related disciplines
- 5 years of clinical research experience
- Centralized monitoring, RBQM, or clinical data review experience
- Strong understanding of clinical trial processes
- Solid understanding and demonstrated application of Good Clinical Practices, ICH Guidelines, and regulatory requirements.
- Highly advanced knowledge of ICH-GCP E6 (R2/R3) and risk-based requirements.
- Experience with clinical trial systems such as EDC, eTMF, IRT, and CTMS.
- Strong interpersonal skills with advanced oral/written communication and presentation skills.
- Proficiency in Microsoft Office tools.
Benefits
- Health insurance plans for employees (and their families) including medical, dental, vision and basic life insurance
- 401k match
- 20 days of PTO
- 10 paid holidays
- Winter company shutdown
- Discretionary annual target bonus
- Stock options