Associate Director, Central Monitoring

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

📋 Description

• Develop, implement, and manage the operational framework for the Central Monitoring Unit.

• Align CMU activities with current Field Monitoring operations.

• Lead and preside over the Clinical Data Quality and Governance Board.

• Foster cross-functional agreement on risk thresholds, QTLs, and KRIs.

• Oversee CMU Standard Operating Procedures, Work Instructions, and Risk Assessment and Categorization Tools.

• Combine data streams from EDC, CTMS, RTSM, eCOA, and Safety DB into a unified surveillance engine.

• Address systemic issues identified by central monitors and facilitate targeted mitigation strategies with Clinical Operations.

• Promote the adoption of risk-based, Critical-to-Quality data review processes within Data Management and Biostatistics.

• Supervise, mentor, and assess Central Monitors.

• Undertake ad-hoc and cross-functional projects as assigned.

⛳️ Requirements

• A bachelor's degree in clinical research, science, or a health-related field is required.

• A master's degree is preferred.

• A minimum of 8 years of progressive experience in clinical research is required.

• Experience in Clinical Operations, Data Management, or Biostatistics is necessary.

• Experience with domestic and international clinical trials is required.

• At least 3 years of direct experience in implementing or managing Risk-Based Quality Management frameworks is essential.

• Prior experience in supervisory roles and department development is required.

• Extensive knowledge of ICH GCP E6(R3) and global regulatory expectations from the FDA, EMA, and MHRA.

• Strong critical and logical thinking skills, including the ability to investigate ambiguous data signals.

• Excellent cross-functional leadership skills and the capability to influence Medical Monitors, Biostatisticians, and Data Managers.

• Proficiency in interpreting clinical data dashboards, visualizations, and KRI/QTL reports.

• Familiarity with Veeva Vault, including CDMS, CTMS, RBM, and QMS.

• Ability to uphold corporate confidentiality.

• Willingness to work flexible hours to accommodate various time zones.

• Ability to travel up to 20% of the time.

• Capability to work in a standard office environment and utilize standard office equipment, including a computer.

🏝️ Benefits

• Discretionary bonus.

• Equity award.

• Options for Medical, Dental, and Vision Plans.

• Health and Financial Wellness Programs.

• Employer Assistance Program (EAP).

• Company Paid and Voluntary Life/AD&D insurance.

• Short-Term and Long-Term Disability coverage.

• Flexible Spending Accounts for Healthcare and Dependent Care.

• 401(k) Retirement Plan with Company Match.

• 529 Education Savings Program.

• Access to Voluntary Legal Services.

• Identity Theft Protection services.

• Pet Insurance options.

• Employee Discounts, Rewards, and Perks.

• Paid Time Off (PTO).

• 11 holidays per year.

• Exempt Employees are entitled to Unlimited PTO.

• Non-Exempt Employees are entitled to 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days, and 1 Cultural Day.

• Access to Health and Wellness tools and resources.

• Opportunities for remote work.

• Flexibility during standard business hours with manager approval.