Associate Director, Field Monitoring Operations
About The Position
The Associate Director, Field Monitoring Operations is responsible for designing, implementing, and overseeing the monitoring strategy, including Risk-Based Quality Management (RBQM) and Decentralized Clinical Trial (DCT) components that safeguard data integrity, patient safety, and regulatory compliance across the organization’s clinical trial portfolio. This role anchors the monitoring function within the broader development pipeline, ensuring that study execution aligns with both internal SOPs and external regulatory expectations. The Associate Director will lead a cross‑functional team of remote Clinical Research Associates and Managers, fostering a culture of continuous improvement and operational excellence. In addition, the Associate Director will act as a primary liaison with external contract research organizations (CROs) and site investigators, translating strategic objectives into actionable monitoring plans that drive timely and high‑quality data capture.
Requirements
- Bachelor’s degree in life sciences, nursing, pharmacy or health-related field. (Master's degree preferred) with 10+ years of progressive industry experience required; or Master’s degree with 8+ years or progressive industry experience required.
- 6+ years management experience leading teams in clinical trial operations required.
- Effective leadership skills with the ability to promote a culture of collaboration and competence for direct and indirect reports.
- Strong knowledge of clinical research, Good Clinical Practices (ICH E6(R3)), and regulatory requirements/guidelines.
- Proven expertise in developing and managing Risk-Based Quality Management (RBQM) strategies.
- Proficiency in interfacing with other functions in clinical research and driving cross-functional alignment.
- Excellent English verbal and written communication skills; good organizational and interpersonal skills.
- Ability to maintain corporate confidentiality at all times.
- Proficiency in MS Office including Word, Excel, PowerPoint, and Outlook.
- Proficient with use of Veeva Clinical Vault, CTMS, and eTMF.
Nice To Haves
- Previous experience working in a dynamic and fast-paced environment is preferred.
Responsibilities
- Provide leadership to team members and study teams to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), ICH Good Clinical Practices (GCPs), and other applicable regulatory requirements as well as management and mentoring of direct reports.
- Design, implement, and oversee Risk-Based Quality Management (RBQM) frameworks and modern data surveillance strategies across the clinical portfolio, ensuring alignment with ICH E6(R3).
- Integrate monitoring activities (including remote, on-site, and decentralized trial approaches) with trial start‑up, site activation, and study close‑out processes, thereby creating a seamless end‑to‑end operational flow.
- Utilize negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional study team partnership and to ensure effective in-house clinical study team operations.
- Directly participates in and contributes to cross-functional and functional teams to discuss, review, and optimize resource management strategy.
- Collaborate with trial execution leadership to ensure optimal resourcing of the study teams.
- Anticipate potential clinical operations process issues and influence and collaborate with the organization in adopting best practices, making recommendations for improvements, or leading development of new processes and continuous improvement of existing processes, tools, reports, and systems.
- Provide quality oversight of trial operations to contribute to inspection readiness.
- Own Clinical Operations Standard Operating Procedures (SOPs), responsible for review and revision or delegating duties as needed, specifically integrating modern risk-management frameworks.
- Contribute to the development and implementation of strategic direction in the conduct of multiple clinical studies.
- Provide management support to the clinical operations team across all trials/programs by way of training, mentoring or review of study specific documents as needed.
- Collaborate with colleagues to ensure cross-team, site learnings, and best practices are shared.
- Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities.
Benefits
- Medical, Dental and Vision Plan Options
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- Healthcare and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- Paid Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
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What This Job Offers
Job Type
Full-time
Career Level
Manager
