Director, Clinical Monitoring

Director, Clinical Monitoring

In order to make an application, simply read through the following job description and make sure to attach relevant documents.

Categories: Clinical Operations

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary:

The Director, Clinical Monitoring is responsible for talent hiring, development, and performance management of Clinical Monitoring staff to ensure conduct of activities is compliant with regulatory requirements, GCP, and Crinetics SOPs. The Director will be accountable for execution of all monitoring and site management activities including onsite and remote visits, investigational product accountability and management, patient recruitment, investigator site file review and reconciliation, and delivery of quality data. The Director is also responsible for strategic development of Clinical Monitoring function including creation of processes and tools/templates to optimize monitoring productivity and ensure the quality and efficient delivery of the Crinetics portfolio.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

* Provide leadership support to clinical study teams and/or Clinical Monitoring Managers with study execution and oversight related to Clinical Monitoring, such as monitoring plans and visit planning. Support team with identification and communication of monitoring risks and proposed mitigations.* Lead team in building strong relationships with Principal investigators, site staff, and vendors.* Ensure Clinical Monitoring Managers develop, maintain and act on metrics related to Monitoring and CRA performance as well as site performance.* Lead the development of Clinical Monitoring procedures and tools/templates for increased efficiency and quality of deliverables. Develop SOPs, WIs, and other procedural documents.* Management and leadership of Clinical Monitoring Managers and if needed, assigned Crinetics and FSP CRAs responsible for Clinical Monitoring activities.* Oversight to ensure adequate resourcing for all CRAs and Clinical Monitoring Managers across Crinetics studies, including both in house regional CRAs and CRO CRAs.* Conduct annual performance assessment activities for direct reports including appraisals, salary recommendations, and promotion justifications for Crinetics employees.* Responsible for all Clinical Monitoring recruiting activities including interviewing, hiring, onboarding, and orientation processes for Crinetics Clinical Monitoring Mangers, CRAs and FSP CRAs.* Accountable for high quality delivery of Clinical Monitoring activities for both insourced and outsourced studies in compliance with regulations, GCPs, Crinetics processes, defined KPIs, metrics, and other performance indicators.* Ensure Clinical Monitoring completes all company, functional and study-level training on time.* Responsible for administrative oversight of direct and indirect reports such as expense reports, travel approvals, and time-off requests.* Support Clinical Monitoring Managers, CRAs, study team, and Quality with preparation and responses to audits or inspections.* Act as a point of escalation for clinical study and Clinical Monitoring teams.* Accountable for accuracy and completeness of the Trial Master File as it relates to Clinical Monitoring activities.* Develop and manage Clinical Monitoring functional resource and budget requirements.* Develops, at a minimum, short-term (
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