Associate Director, Clinical Operations - Centralized Monitoring

Job Description

Oversee clinical operations activities, which may include clinical project management, clinical site management (e.g., regulatory documentation, study initiation, site monitoring), and/or clinical systems management (e.g., CTMS, TMF documentation review/collection). Must have a solid understanding of regulatory requirements (FDA, GCPs/ICH guidelines), data management/analysis, and scientific/technical writing processes and requirements.

Support multiple government or commercial contracts across various therapeutic areas, such as infectious diseases (vaccines and therapeutics), oncology, medical devices, or drug abuse.

Manage the oversight of project management for various functional areas within one or more complex drug development programs, ensuring deliverables are met within budget and on time.

Communicate effectively within a matrix organization and represent the clinical team in cross-functional collaborations.

Provide operational expertise to support functional areas at the program/project level.

Collaborate with the Director and other departments, leading clinical operations strategy to support clinical trial activities.

Keep leadership informed about the overall status of clinical programs/projects, including potential issues and mitigation strategies.

Ensure processes and workflows are documented and followed according to timelines. Identify and address delays, propose solutions, and improve the efficiency and quality of deliverables. Maintain accuracy and attention to detail in a fast-paced environment with shifting priorities.

Support and comply with the company’s Quality Management System (QMS) policies and procedures. Drive project and company performance improvements, including corrective and preventive actions (CAPA), as needed. Conduct risk-based quality content reviews and monitor internal/external KPIs, as required by clients.

Contribute to corporate initiatives such as process streamlining, SOP development, and process improvement.

Take on line management responsibilities, including staff hiring, resource management, tracking, and level of effort projections for clinical operations departments or project functional areas.

Participate in proposal writing for government and commercial clients, budget development, and bid defense meetings, as needed.

Support inspection readiness, assist with department audit preparation, and manage post-inspection follow-up activities.

Establish Risk-Based Quality Management and Centralized Monitoring processes at the corporate level and for relevant clinical trials.

Review protocols to ensure that the set-up, review, and reporting requirements for Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) are met and standardized.

Provide technical oversight, guidance, and coordination for all central monitoring activities.

Perform central monitoring activities, including reviewing system outputs, proposing suggestions for signal management, and following up with the study team to ensure resolutions.

Job Requirements

A broad, multidisciplinary understanding of pharmaceutical clinical research and development processes, with hands-on experience in regulatory affairs, clinical operations, or clinical trial management/monitoring. Experience may include clinical study design, execution, reporting, and the product development lifecycle.

Ability to mentor staff and achieve high-quality performance through risk management and the implementation of corrective/preventive actions, when necessary.

Strong facilitation, presentation, problem-solving, and conflict resolution skills. Must be adaptable to changing priorities and possess excellent oral and written communication abilities. Strong attention to detail, including the ability to QC information, and experience with clinical research databases/systems/tools.

Proven leadership skills, including change management, people development, strategic thinking, and influence.

Advanced ability to manage team resources to meet departmental objectives.

Proficiency in Microsoft Word, PowerPoint, Excel, and Microsoft Project is required.

Proposal writing and bid defense experience is a plus.

Experience in Infectious Disease/HIV clinical trials, Oncology, or working with Phase 1 protocols or government contracts is a plus.

At least 10 years of experience in the pharmaceutical or biotechnology industry, including experience with Contract Research Organizations (CROs) or other clinical trials/research environments. This should include at least 6 years of project management or equivalent clinical trials and operations management experience.