Associate Director – Field Monitoring Operations

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

📋 Description

• Oversee the monitoring strategy, which encompasses Risk-Based Quality Management (RBQM) and Decentralized Clinical Trial (DCT) elements, throughout the clinical trial portfolio.

• Ensure the integrity of data, prioritize patient safety, and maintain regulatory compliance.

• Supervise remote Clinical Research Associates and Managers, providing mentorship to direct reports.

• Collaborate with contract research organizations (CROs) and site investigators.

• Guarantee adherence to protocols, SOPs, ICH GCPs, and relevant regulations during trials.

• Design and implement RBQM frameworks and advanced data surveillance strategies in accordance with ICH E6(R3).

• Combine remote, on-site, and decentralized monitoring with trial initiation, site activation, and study closure.

• Enhance cross-functional study team operations, resource management, and study team staffing.

• Detect issues in clinical operations processes and spearhead best-practice and continuous improvement efforts.

• Provide quality oversight and assist in preparing for inspections.

• Take ownership of, review, revise, and delegate responsibilities related to Clinical Operations SOPs.

• Contribute to the strategic direction of multiple clinical studies.

• Offer training, mentorship, and review of study-specific documents.

• Share insights and best practices from cross-team and site experiences.

• Execute ad-hoc and cross-functional projects as required.

⛳️ Requirements

• A Bachelor’s degree in life sciences, nursing, pharmacy, or a health-related discipline with over 10 years of progressive industry experience; or a Master’s degree with more than 8 years of progressive industry experience.

• At least 6 years of management experience leading teams in clinical trial operations.

• Familiarity with clinical research, Good Clinical Practices (ICH E6(R3)), and regulatory requirements/guidelines.

• Proficiency in developing and managing Risk-Based Quality Management (RBQM) strategies.

• Ability to interface effectively with clinical research functions and foster cross-functional alignment.

• Exceptional verbal and written communication skills in English.

• Capacity to uphold corporate confidentiality.

• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.

• Experienced in using Veeva Clinical Vault, CTMS, and eTMF.

• Willingness to travel up to 75% of the time based on study needs.

• Flexibility to work varied hours across multiple time zones.

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

🏝️ Benefits

• Opportunities for professional development.

• Discretionary bonus potential.

• Equity awards.

• Options for Medical, Dental, and Vision Plans.

• Health and Financial Wellness Programs.

• Employer Assistance Program (EAP).

• Company-paid and voluntary Life/AD&D coverage.

• Short-Term and Long-Term Disability benefits.

• Flexible Spending Accounts for Healthcare and Dependent Care.

• 401(k) Retirement Plan with company matching contributions.

• 529 Education Savings Plan.

• Voluntary legal services.

• Identity theft protection.

• Pet insurance options.

• Employee discounts, rewards, and perks.

• Paid Time Off (PTO), which includes 11 Holidays.

• Exempt employees are eligible for Unlimited PTO.

• Non-exempt employees qualify for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days, and 1 Cultural Day.

• Access to health and wellness tools and resources.

• Flexible work schedules available with manager approval.