Associate Manager, Centralized Monitoring

Position Summary: The Associate Manager, Centralized Monitoring is responsible for executing and overseeing centralized monitoring activities across clinical trials using a risk-based quality management (RBQM) framework. The role focuses on proactive signal detection, data surveillance, risk identification support, and escalation to support study quality, participant safety, and regulatory compliance. This position also contributes to process improvement, and cross-functional collaboration related to centralized monitoring activities. Incumbent will support cross-functional collaboration across multiple clinical studies, with a focus on regulatory compliance and inspection readiness.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Support the execution of centralized monitoring strategies for studies ensuring setup aligns with Crinetics’ RBQM best practices.
• Perform ongoing centralized monitoring reviews using clinical, operational, and quality data sources (e.g., EDC, CTMS, safety, vendor data).
• Identify emerging study-level and site-level risks through Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and analytical outputs.
• Support the evaluation of trends, data anomalies, protocol deviations, and performance metrics to detect potential quality or compliance issues.
• Document and report signals, findings, and recommendations within designated systems (e.g., CTMS, RBQM platform).
  • Support study teams’ understanding of the significance and root causes of centralized monitoring findings.
• Contribute to the development and maintenance of RBQM documentation, including:
  • Centralized Monitoring Plans
  • KRI and QTL threshold definitions
  • SDV and SDR strategies  
• Collaborate with Clinical Monitoring to support alignment of monitoring approaches with ICH-GCP E6 (R2/R3) and internal SOPs.
• Provide input on targeted monitoring actions, such as focused SDV, site follow-up, or additional oversight.
• Support presentation of centralized monitoring strategies at CRO or internal study kick-off meetings.
• Support leadership with the evaluation of the quality and usefulness of data metrics and reports used for centralized monitoring  and provide input for opportunities to improve efficiency, signal detection, and monitoring.
• Support oversight of centralized monitoring vendors, tools, or platforms, as needed.
• Participate in ongoing improvements in standardizing technologies, systems, processes, and training materials for centralized monitoring and RBQM.
• Other duties as assigned.

Education and Experience:

Required:

• Bachelor’s degree in life sciences, health sciences, or related disciplines
• 5 years of clinical research experience, including experience in:
  • Centralized monitoring, RBQM, or clinical data review, and/or
  • Clinical Operations, CRA, or Clinical Trial Management roles
• Experience in all stages of drug development/pharma (study start-up, maintenance, and database lock) with a strong understanding of clinical trial processes, SDV/SDR strategies, and monitoring aggregate data trends.
• A 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. Experience with RBQM technology is strongly preferred.
• Solid knowledge of RBQM methodologies in the clinical trial industry such as TransCelerate and/or WCG Avoca.
• Strong interpersonal skills with advanced oral/written communication and presentation skills.
• 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, analytical and collaborative abilities.
• Proficiency in Microsoft Office tools.

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Travel:

You may be required to travel for up to 5% of your