The Director, Clinical Operational Excellence is responsible for leading a Center of Excellence aimed at improving the operational performance and quality of all clinical trials sponsored by Deciphera Pharmaceuticals.Lead the internal Cross Functional Trial Teams in the establishment of Risk Based Quality Management best practices.  Works with all functions to ensure compliant risk management best practices are deployed, and monitoredEstablish a framework for collecting clinical trial performance metrics to be used in the management of CROs and vendors working on Deciphera-sponsored trials.  Performance metrics will be used to benchmark individual clinical trial performance, whether the trial is insourced or outsourced and to establish a comparison against industry benchmarks.Drives clinical operations innovation though the process of identification and implementation of new technologies, processes and process improvement initiatives.Drives the outsourcing and/or management of the eTMF for internally managed clinical trialsWhat You’ll Do:Drives project risk analysis and develops solutions to a variety of complex problems. Ensures that Clinical Trial Teams proactively identify and manage risks through the use of risk identification, risk monitoring techniques and the implementation of Quality Tolerance Limits according to ICH E6(R2).Provides advice, identifies issues, analyzes trends, implements standardized quality metrics, deploys compliance measures, identifies quality risks and events with each trial team, generates and facilitates Corrective Action/Preventive Action (CAPA), etc. Contributes to the development (content) and implementation (execution) of standards of all study-related operational plans (e.g., manuals, trackers, processes, etc.) ensuring a “fit for purpose” and consistency/standardization between teams to be deployed within each clinical trial team.Delivers Clinical Operations expertise and strategic leadership in the evaluation, selection, oversight and management of Global Contract Research Organizations (CROs) and other external vendors.Compares industry standard benchmarking performance insights and analytics to Deciphera internal metrics (e.g., OKMs/KPIs/KQIs/KRIs) to be used by study management and Vendor Performance and Strategy to monitor and improve clinical trial and vendor performance.Manage Cross Functional TMF compliance related activities inclusive of holistic evaluation of TMF Health and TMF inspection readiness support.Leads the development, enhancement and implementation of best practices concerning quality and compliance by building quality into internal processes leading to a state of constant inspection readiness.  Acts as an internal SME for quality-related matters.Maintain awareness of existing and new internal and external regulations and guidance pertaining to GCP, ICH, data integrity, system validation etc. assessing impact and providing recommendations where requiredWhen applicable - Responsible for hiring, training, mentoring trial team staff.   Including hiring, performance management, retention, and engagement as well as succession planningLeads and implements a culture to making Deciphera clinical trials patient and site centric through the identification, evaluation and recommendation of innovative ideas and technologies.Demonstrates excitement around the Vison and Mission of Deciphera and the departmentOther duties as assigned
