Manager of Monitoring Operations

Job Overview

We are in search of a highly skilled Monitoring Manager to spearhead a dynamic team of Clinical Research Associates (CRAs) and Lead CRAs. This pivotal role will involve close collaboration with cross-functional teams, ensuring that clinical trials are executed efficiently while adhering to all regulatory standards. Your strategic oversight will be essential in evaluating resource requirements, managing team performance, and fostering the development of each team member. Your expertise in assessing the monitoring team's capabilities will be instrumental in driving the success of our clinical trials.

Key Responsibilities

• Team Development: Design and implement comprehensive onboarding and ongoing training initiatives to prepare the team for optimal performance while meeting critical deadlines.
• Recruitment & Resource Planning: Engage actively in the recruitment and selection processes for CRAs and Lead CRAs. Utilize advanced technology to assess resourcing needs and maintain an updated database to inform hiring decisions.
• Performance Management: Leverage metrics and key performance indicators to effectively manage team performance, creating targeted action plans to address any performance gaps. Conduct regular reviews to provide necessary guidance for meeting objectives.
• Site Visits & Compliance: Conduct on-site evaluations to confirm that CRAs are complying with study protocols and organizational processes. Offer actionable feedback and implement improvement strategies as needed.
• Data Management & Reporting: Ensure the accuracy and timely submission of regulatory documentation and data entry into the Trial Master File (TMF). Approve time reporting and expenditures for direct reports.
• Career Development: Facilitate team members in establishing and achieving their career development targets through consistent check-ins, performance evaluations, and access to growth opportunities.
• Collaboration: Contribute to departmental and cross-functional initiatives and partake in study budget assessments.
• Mentorship: Provide guidance and support to cultivate a constructive, high-performing work environment.
  
  

Qualifications

• Education & Experience: A Bachelor's degree coupled with a minimum of six years of experience as a Clinical Research Associate or an equivalent blend of education, training, and experience. At least one year of management or leadership experience is required, preferably within a clinical research environment.
• Preferred: Experience in ophthalmic research is advantageous, along with expertise in evaluating monitoring capabilities in clinical settings.
  
  

Required Skills

• Exceptional attention to detail for reviewing CRA visit reports and eTMF.
• Strong verbal and written communication skills.
• Comprehensive understanding of federal regulations and Good Clinical Practices (GCPs).
• Ability to establish clear objectives and maintain focus while collaborating with team members.
  
  

Career Growth Opportunities

We are committed to your professional growth, offering pathways for development through regular performance reviews, mentorship, and access to continuous learning opportunities.

Company Culture And Values

Join a global organization that emphasizes collaboration and shared values to achieve significant outcomes. We are dedicated to fostering a diverse and inclusive work environment where all employees can thrive and contribute to impactful ophthalmic research.

Compensation And Benefits

• Comprehensive healthcare options (Medical, Dental, Vision) available from day one.
• Generous paid time off, unlimited sick leave, and 14 company-paid holidays.
• Competitive salary with 401(k) matching and company-sponsored life and disability insurance.
• Family support initiatives, including adoption and fertility assistance, alongside 16 weeks of paid parental leave.
• Opportunities for professional advancement and career progression.
  
  

Employment Type: Full-Time