Parexel FSP / ExecuPharm is seeking a Sr. Manager, Analytics and Metrics to advance the use of analytics and metrics related to Development GCP, GLP, GVP and Electronic Systems activities. In this role, you will be responsible for cultivating the analytics and metrics that support RDQ and Development strategic direction and leadership. This role will be leading the development and driving the utilization of metrics, analytics and insights that facilitate RDQ oversight of quality performance. The individual in this role will help to ensure independent oversight and will represent the metrics and analytics for Quality Assurance.
In addition to analytics & metrics skills, this individual must have good leadership skills, knowledge of the regulations governing drug development and post marketing activities, and excellent presentation skills.
Establish quality analytics & metrics and supporting tools to intake Development information and create visuals as outputs appropriate for presenting governance metrics to various levels including executive level management.
The role will also support the monitoring and implementing quality performance improvement activities. This includes, for example, quality management system actionable metrics, study-level quality metrics and vendor quality performance metrics.
Determine appropriate quality thresholds for acceptable and at-risk performance. Gain insights from metrics and other mechanisms to uncover trends and support mitigation requirements.
Lead regular analytics and metrics review cycle to assure management visibility of quality performance across Development. This includes quality metrics and trending input to various quality forums and the flow of messaging to management.
As a part of the quality governance structure, build the Analytics and Metrics program and assure consistency of terminology and tools as it is applied in various quality processes (e.g., audit, vendor, risk-based quality management, etc.).
Lead regular analytics and metrics reviews to drive active GCP, GLP, GVP and electronic systems risk monitoring and mitigation.
Train staff as needed on analytics and metrics methodology. This includes fostering a commitment to quality in individuals and a culture of quality within the organization.
Bachelor’s degree with 8+ years of R&D
Must have, Quality Metrics and Analytics experience
Experience in building analytics and Metrics processes, end-to-end data analytics, trending and visualizations using tools such as Spotfire, Tableau, Power BI, or equivalent
Must have broad GCP/GLP/GVP experience. Compliance experience in a Bio-pharma sponsor organization required
Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R2) required
Exceptional verbal, written, interpersonal skills to include delivering presentations to executives, examples may be requested as applicable
Demonstrated effective verbal and written communication skills
Excellent organizational and project management skills
Able to effectively lead and mentor cross-functional teams
Parexel is one of the world's leading global CROs, providing the clinical development capabilities and integrated consulting expertise it takes to streamline development every step of the way — faster and more cost-effectively. As part of Parexel, Parexel FSP/ExecuPharm works in strategic partnership with biopharmaceutical companies and provides qualified and talented professionals through functional outsourcing models to support the development and delivery of new therapies. At Parexel FSP/ExecuPharm, we are proud of our top 3 client relationship rating and our world-class network of experts who help scale clinical trials, accelerate timelines, and maximize efficiency throughout development.