Manager, Clinical Monitoring

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

📋 Description

• Assist in managing global and regional clinical trial operations as well as Clinical Monitoring oversight.

• Oversee Clinical Research Associates and aid in the development of monitoring processes, procedures, and templates.

• Create and execute risk-based monitoring strategies for assigned studies, both in-house and regionally.

• Lead monitoring initiatives, including the review of protocols, CRFs, completion guidelines, study manuals, and related documents.

• Draft or review Clinical Monitoring Plans to ensure compliance by CRAs.

• Organize CRA monitoring visit schedules based on risk indicators and site metrics.

• Review and finalize regional CRA visit reports while following up on any outstanding trip reports and correspondence.

• Monitor action items, queries, CRA performance metrics, site status, compliance, trends, and overall monitoring metrics.

• Assist in implementing corrective actions at sites.

• Support the setup, maintenance, quality review, and final reconciliation of the TMF.

• Develop and manage monitoring oversight strategies in collaboration with CRO and FSP partners.

• Supervise monitoring oversight visits and evaluate CRO CRA monitoring reports.

• Guide and mentor CRA team members throughout the study lifecycle, from startup to closure.

• Provide management and oversight for Crinetics and FSP CRAs.

• Conduct monitoring assessments and FSP oversight visits while offering support, training, or performance management.

• Ensure sufficient CRA resources and plan for reassignments or additional staffing as needed.

• Carry out annual performance evaluations, salary recommendations, and promotion justifications.

• Engage in interviewing, hiring, onboarding, and orientation procedures.

• Conduct or coordinate training on SOPs, WIs, ICH-GCP, local regulations, and role-specific subjects.

• Address training deficiencies and oversee team administration, including expenses, travel approvals, and time-off requests.

• Escalate issues related to performance, resourcing, training, and study matters to senior leadership.

• Assist in audit and inspection responses.

• Perform additional duties as assigned.

• Travel may be required for up to 30% of the time.

⛳️ Requirements

• Bachelor’s degree in biological sciences or a related field.

• Minimum of 7 years of experience in the biotechnology or pharmaceutical sector.

• At least 2 years in a supervisory capacity.

• Experience with endocrine disorders is preferred.

• Strong critical thinking, root cause analysis, and problem-solving abilities.

• Knowledge and demonstrated application of Good Clinical Practices, ICH Guidelines, and regulatory standards.

• Capacity to adhere to safety regulations and maintain privacy and confidentiality.

• Comprehensive experience in cross-functional drug development.

• Previous experience with regulatory inspections is preferred.

• Exceptional writing skills for clinical trial documentation.

• Strong interpersonal, oral/written communication, and presentation abilities.

• Excellent negotiation skills with a tactful approach.

• Proven leadership and management capabilities.

• Ability to evaluate risks, analyze options, and manage outcomes effectively.

• Awareness of current trends in the clinical trial industry.

• Monitoring experience during startup, execution, and closeout phases is preferred.

• Strong preference for experience with risk-based monitoring processes.

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

• Ability to sit for extended periods at a desk, and use a telephone and keyboard.

• Capability to walk and lift up to 25 lbs. as necessary.

🏝️ Benefits

• Discretionary annual target bonus.

• Stock options.

• Employee Stock Purchase Plan (ESPP).

• 401k matching contributions.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• Basic life insurance.

• 20 days of paid time off (PTO).

• 10 paid holidays.

• Company shutdown during winter.

• Commitment to equal employment opportunities.

• Provision of reasonable accommodations for individuals with disabilities.