Associate Director, Clinical Trial Management

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

📋 Description

• Lead, direct, and manage Clinical Trial Managers and Senior Clinical Trial Managers.

• Supervise monitoring and site management activities to ensure clinical targets are achieved.

• Serve as the primary contact for monitoring strategy and internal and external alignment.

• Advise teams and sponsors on implementing effective, high-quality risk-based monitoring solutions.

• Oversee the identification of critical data and processes, risk assessment, risk tracking, and mitigation strategies.

• Coordinate access to data necessary for risk-based monitoring.

• Provide operational oversight, prioritize tasks, monitor work and compliance with metrics, and develop contingency plans.

• Analyze performance and quality metrics related to patient safety, data integrity, and the success of risk-based monitoring.

• Escalate and manage clinical, central monitoring, risk-based monitoring, and project-related risks and issues.

• Ensure team tasks align with sponsor expectations, contractual obligations, regulations, SOPs/WIs, and ICH GCP requirements.

• Cultivate customer relationships, manage expectations, and escalate significant risks and issues.

• Identify areas for process improvement and increased efficiency.

• Participate in committees, workgroups, marketing activities, client presentations, and proposal development.

• Assist Business Development during bid defenses and proposal processes.

• Provide line management, administrative oversight, professional development, performance reviews, and mentoring.

• Establish staff objectives, delegate tasks, and review workload, utilization, productivity, and quality.

• Manage resource availability, resolve staffing conflicts, and support hiring and staff development.

• Promote staff retention and ensure necessary training and documentation are completed.

• Provide compliance updates to management.

• Participate in clinical trial management delivery audits and prepare team members for audits.

⛳️ Requirements

• Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.

• A Master’s degree or a degree in health data sciences is preferred.

• Familiarity with Good Clinical Practice/ICH E6 (R2) Guidelines and/or other relevant regulatory requirements.

• Preference for familiarity with Risk-Based Monitoring Strategies processes and tools.

• Understanding of project risk and issues management.

• Experience in interactions with sponsors, including conflict resolution and handling difficult conversations.

• Ability to persuade and influence at all levels, both internally and externally.

• Proven experience in operational efficiency and utilizing data and metrics to drive performance and decision-making.

• Strong computer skills and a willingness to adopt new technologies.

• Proficient in MS Excel (sorting, filtering, calculating, pivoting).

• Familiarity with Analytical Data Visualization Tools.

• Knowledge of statistical analysis techniques, visualizations, and tools, including Cluepoints, Medidata-CSA, Hy’s Law, Funnel Plots, and Box and Whiskers.

• Understanding of Lean Six Sigma and RACT tools.

• Strong analytical skills with a solid grasp of statistical concepts.

• Well-developed therapeutic expertise.

• Exceptional verbal and written communication abilities.

• Strong negotiation, organizational, problem-solving, leadership, tactical, and strategic thinking skills.

• Capability to anticipate and address critical issues while proactively developing contingency plans.

• Familiarity with financial concepts related to forecasting, budgeting, and proposal generation.

• Knowledge of resource utilization management, hiring targets, and productivity metrics.

• Understanding of workflow processes, roles, and responsibilities across various functional areas.

• Ability to teach, train, and mentor employees at all levels.

• Above-average attention to detail, accuracy, organizational, interpersonal, and team-oriented skills.

• Comfortable making challenging decisions and effectively communicating those decisions and their rationale both internally and externally.

• Willingness to travel, with less than 30% travel required.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Access to technical and therapeutic area training.

• Peer recognition and comprehensive rewards program.

• Option for a company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company matching 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on both company and individual performance.

• Flexible paid time off (PTO) and sick leave.