Associate Manager, Clinical Monitoring

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide support for global and regional clinical trial operations (CTO) as well as Clinical Monitoring management in overseeing clinical site management and monitoring activities conducted by Crinetics or its outsourcing partners.

• Execute Clinical Monitoring visits for designated Crinetics studies.

• Spearhead monitoring activities for assigned studies, including the examination of protocols, CRFs, completion guidelines, and study manuals.

• Create or review the Clinical Monitoring Plan in collaboration with the CTO, ensuring compliance from CRAs with the current plan.

• Organize and manage the CRA monitoring visit schedule for each assigned study, ensuring that visit frequency and scheduled on-site time aligns with risk-based indicators and site metrics.

• Review and finalize visit reports for regional CRAs managed by Crinetics, adhering to study timelines.

• Monitor and act on metrics related to CRA performance or site status.

• Assist in the development and management of Clinical Monitoring budget requirements for assigned studies.

⛳️ Requirements

• Bachelor’s degree in biological sciences or a related field, with a minimum of 5 years of experience in the biotechnology/pharmaceutical industry.

• Preference for experience in endocrine disorders.

• Proven monitoring experience during the startup, execution, and closure phases of clinical studies; strong preference for experience utilizing risk-based monitoring processes.

• Prior experience as a Lead CRA, Trial Manager, or in a similar role is highly preferred.

• Ability to demonstrate critical thinking, root cause analysis, and problem-solving skills to assist CRAs in identifying site process failures; help CRAs develop corrective and preventative measures to achieve compliance.

• Understanding and practical application of Good Clinical Practices, ICH Guidelines, and regulatory requirements.

• Extensive experience in cross-functional drug development, with prior regulatory inspection experience preferred.

• Exceptional writing abilities related to the preparation of clinical trial documents.

• Strong interpersonal skills with excellent oral/written communication and presentation capabilities.

• Outstanding negotiation skills with a diplomatic approach that enhances the value of services obtained and outcomes achieved.

• Proven leadership abilities.

🏝️ Benefits

• Health insurance plans for employees (and their families) that include medical, dental, vision, and basic life insurance.

• 20 days of paid time off (PTO).

• 10 paid holidays.

• Winter company shutdown.

• Discretionary annual target bonus.

• Stock options.

• Employee Stock Purchase Plan (ESPP).

• 401k matching.