Director, Clinical Studies Data Management

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

We are looking for an experienced Clinical Data Management leader to lead design, execution, and maintenance of data collected during the course of clinical studies in pharmaceutical and diagnostic studies from Ph 1 to Ph 4, with registrational and non-registrational intent. We expect this individual to lead a growing Clinical Data Management team, collaborating cross-functionally with Tempus RWD groups, medical teams, and life science facing business units. This individual should have in-depth knowledge of technical systems, project management, GCP quality compliance, and regulatory requirements and guidance. 

What you’ll do:

• Serve as the data management subject matter expert, overseeing all aspects of clinical data management across all trials and all clients, ensuring adherence to timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, HIPAA, and ICH guidelines
• Promote standardization, automation, innovation, process improvement, and technology  enhancement in CDM and beyond to increase clinical study execution efficiency
• Strategically streamline data management approaches to data quality and data integrity within  and across programs through adoption of standards and best practices to ensure consistency in conjunction with GCP quality standards across studies and programs (inclusive of Case Report Forms (CRF), CRF completion guidelines, annotated CRFs, data handling plan, data entry review guidelines, edit check specifications, data transfer specifications, and data monitoring/audit plans/procedures. 
• Contribute to process improvements and initiatives, such as building and maintaining trial databases and dashboards, analyzing metrics/performance, and plans for statistical analysis.
• Facilitate effective planning and execution of all Tempus data management tasks
• Partner with colleagues and clients to develop timelines and budgets for data management activities, setting measurable objectives, monitoring progress, identifying issues, and strategies for resolution
• Review and provide input into protocols, SAP, IB, CSR and other clinical study documents during development 
• Work to ensure on-time achievement of major data management deliverables and milestones in coordination with other functions 
• Oversee or lead internal study team in data review; Perform data review for quality issues and  general data trends. Provide guidance to others on program-level internal data review standards
• Lead EHR to EDC initiatives for innovative Tempus studies with deep knowledge of data quality, regulatory guidance, and quality compliance

Required Knowledge and Skills:

• 7+ years of experience in clinical data management, preferably from biopharma industry and/or CRO perspective
• 3+ years of experience managing a data management team
• Bachelor’s degree in a scientific, computer information systems, or healthcare discipline preferred
• Full understanding of data management and database programming tasks, regulatory requirements, and data standards such as CDASH, CDISC, ADaM; Strong understanding of GCP/ICH and applicable regulations
• Experience managing DM activities for Phase I through IV studies, experience in oncology clinical  trials and early phase is critical
• Experience in database development and data management using various EDC systems, including such as Medidata, Bioclinica, Medrio, REDcap
• Experience with at least one of SAS, Tableau, or other BI as preferred to oversee data quality
• Expertise in clinical oncology indications, end points, data flow, data integrity/quality and monitoring standards
• Experience with audits and vendor management
• Registration (BLA/NDA/MAA/PMA) submission experience highly desired 
• Strong project management skills and ability to lead and collaborate effectively with cross-functional teams
• Ability to effectively prioritize in a challenging, rapidly changing, and time sensitive environment with minimal guidance
• Excellent interpersonal and communications skills (verbal and written), as well as problem solving and organization skills 
• Self-motivated, proactive, and resourceful  
• Excellent ability to build and lead virtual teams independently and with authority
• Demonstrated success in working with cross-functional teams and external stakeholders
• Outstanding negotiation and organizational skills 
• Excellent ability to lead cross-functional initiatives 
• Demonstrated proactive thought process to minimize and mitigate risk independently
• Demonstrated ability to conduct root cause analysis cross-functionally in business problem solving and process improvement development 
• Excellent presentation skills: internal, external
• Experience working with EMRs such as EPIC preferred
• Experience working in a startup environment is preferred