Associate Director, Central Monitoring

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Oversee and direct the Central Monitoring function for all of Jazz's sponsored clinical trials.

• Establish, develop, and sustain Key Risk Indicators (KRIs) along with centralized statistical monitoring analytics and dashboards at the study, site, and CRA levels.

• Evaluate centralized data trends and risk signals to identify when adjustments to the monitoring strategy are necessary.

• Manage the process of initiating and documenting risk-based alterations to monitoring plans.

• Assist in the creation of Risk Based Monitoring Strategy Documents and study monitoring plans.

• Act as the functional lead for central monitoring technology platforms.

• Present central monitoring results, risk trends, and suggested actions to study teams, governance committees, and senior leadership.

• Ensure that central monitoring documentation, KRI justifications, and escalation histories are prepared for inspections.

• Collaborate with Site Monitoring leadership to relay findings to field-based CRAs and Lead CRAs.

• Provide guidance, mentorship, and growth opportunities for central monitoring team members.

• Advocate for continuous improvement initiatives, including automation, machine learning, and AI-driven risk detection.

• Represent Central Monitoring in cross-functional processes and technology projects, as well as governance discussions with external partners and CROs.

• Support the development of RBQM strategy, standards, and training.

⛳️ Requirements

• Generally, 8-10+ years of experience in clinical research or clinical operations within the pharmaceutical or biotechnology sectors.

• Substantial hands-on experience in central/statistical monitoring or risk-based quality management (RBQM).

• Proven expertise in defining, implementing, and interpreting KRIs.

• Strong familiarity with ICH E6(R2/R3), principles of risk-based quality management, and relevant global regulatory requirements.

• Practical experience with central monitoring/statistical analytics platforms, Clinical Trial Management Systems (CTMS), and Electronic Data Capture (EDC) systems.

• Experience in managing large, multi-source clinical trial datasets.

• Proficient data analytics and interpretive abilities.

• Experience in people leadership, including managing and developing a team of central monitoring analysts or associates.

• Exceptional written, verbal, and presentation skills.

• Strong business acumen.

• Demonstrated experience collaborating with Site Monitoring/CRA teams, Biostatistics, and Data Management in a matrixed environment.

• Passion for innovation, particularly in applying AI and advanced analytics to clinical trial oversight.

• Willingness to travel for business, including international travel, under 10% of the time.

• A bachelor's degree in a life science, nursing, or a related field is required.

• Experience in the pharmaceutical or biotechnology industry is required.

• Previous people management experience is required.

🏝️ Benefits

• Discretionary annual cash bonus or incentive compensation.

• Discretionary equity grants.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k retirement savings plan.

• Flexible paid vacation.

• Remote work arrangement.