Associate Manager, Clinical Monitoring
Crinetics Pharmaceuticals
June 24, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Position Summary
The Associate Manager, Clinical Monitoring supports global and regional clinical trial operations and Clinical Monitoring management in overseeing clinical site management and monitoring activities performed by Crinetics or an outsourcing partner. May conduct Clinical Monitoring visits for assigned studies. May support development of monitoring and site management processes, procedures, and tools/templates.
Essential Job Functions and Responsibilities
- Implement strategy for in-house/regional monitoring activities on assigned studies using risk-based approaches.
- Lead monitoring activities: review protocols, CRFs/completion guidelines, study manuals, and related documents.
- Author or review Clinical Monitoring Plans; ensure CRA compliance.
- Manage CRA monitoring visit schedules aligned with risk-based indicators and site metrics.
- Review/finalize visit reports; follow up on outstanding trip reports and follow-up letters.
- Track action items/queries; maintain/act on CRA performance and site status metrics.
- Support site corrective actions for issues identified during monitoring.
- Track/report compliance trends and metrics; support TMF set-up/maintenance and reconciliation as needed.
- Manage monitoring oversight strategy for CRO/FSP partners; conduct monitoring oversight visits (MOVs) and review/escalate CRO findings.
- Conduct/participate in clinical monitoring visits.
- Mentor CRA team from start-up through closure; ensure CRA resourcing and support re-assignment.
- Escalate study issues affecting deliverables; support responses to audits/inspections.
- Assist with policies/SOPs; may conduct monitoring assessment/FSP oversight visits.
- Support development and management of Clinical Monitoring budget requirements.
- Other duties as assigned.
Required Qualifications
- BS in biological sciences (or related) and 5+ years in biotech/pharma; endocrine disorders experience preferred.
- Monitoring experience across clinical study start-up, execution, and close-out; risk-based monitoring preferred.
- Lead CRA/Trial Manager (or equivalent) experience strongly preferred.
- Critical thinking, root-cause analysis, and problem-solving; ability to drive corrective/preventive actions to compliance.
- Demonstrated application of GCP, ICH, and regulatory requirements; safety compliance; privacy/confidentiality.
- Cross-functional drug development experience; prior regulatory inspection experience preferred.
- Strong clinical trial document writing; excellent communication/presentation skills.
- Negotiation skills and tact; demonstrated leadership.
- Risk assessment and outcome management; knowledge of latest clinical trial industry trends.
Travel
- Up to 5%.
Benefits (as listed)
- Discretionary annual target bonus; stock options; ESPP; 401k match; medical/dental/vision/basic life; 20 days PTO; 10 paid holidays; winter company shutdown.
The Associate Manager, Clinical Monitoring supports global and regional clinical trial operations and Clinical Monitoring management in overseeing clinical site management and monitoring activities performed by Crinetics or an outsourcing partner. May conduct Clinical Monitoring visits for assigned studies. May support development of monitoring and site management processes, procedures, and tools/templates.
Essential Job Functions and Responsibilities
- Implement strategy for in-house/regional monitoring activities on assigned studies using risk-based approaches.
- Lead monitoring activities: review protocols, CRFs/completion guidelines, study manuals, and related documents.
- Author or review Clinical Monitoring Plans; ensure CRA compliance.
- Manage CRA monitoring visit schedules aligned with risk-based indicators and site metrics.
- Review/finalize visit reports; follow up on outstanding trip reports and follow-up letters.
- Track action items/queries; maintain/act on CRA performance and site status metrics.
- Support site corrective actions for issues identified during monitoring.
- Track/report compliance trends and metrics; support TMF set-up/maintenance and reconciliation as needed.
- Manage monitoring oversight strategy for CRO/FSP partners; conduct monitoring oversight visits (MOVs) and review/escalate CRO findings.
- Conduct/participate in clinical monitoring visits.
- Mentor CRA team from start-up through closure; ensure CRA resourcing and support re-assignment.
- Escalate study issues affecting deliverables; support responses to audits/inspections.
- Assist with policies/SOPs; may conduct monitoring assessment/FSP oversight visits.
- Support development and management of Clinical Monitoring budget requirements.
- Other duties as assigned.
Required Qualifications
- BS in biological sciences (or related) and 5+ years in biotech/pharma; endocrine disorders experience preferred.
- Monitoring experience across clinical study start-up, execution, and close-out; risk-based monitoring preferred.
- Lead CRA/Trial Manager (or equivalent) experience strongly preferred.
- Critical thinking, root-cause analysis, and problem-solving; ability to drive corrective/preventive actions to compliance.
- Demonstrated application of GCP, ICH, and regulatory requirements; safety compliance; privacy/confidentiality.
- Cross-functional drug development experience; prior regulatory inspection experience preferred.
- Strong clinical trial document writing; excellent communication/presentation skills.
- Negotiation skills and tact; demonstrated leadership.
- Risk assessment and outcome management; knowledge of latest clinical trial industry trends.
Travel
- Up to 5%.
Benefits (as listed)
- Discretionary annual target bonus; stock options; ESPP; 401k match; medical/dental/vision/basic life; 20 days PTO; 10 paid holidays; winter company shutdown.