Clinical Data Manager

## Clinical Data Manager Apply:
Remote - Illinois:
Full time:
Posted Yesterday:
JR
** 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.

The Lead Clinical Data Manager will contribute and lead data management activities in support of client  studies across all stages of clinical drug development. They will be responsible for working with cross  functional teams leading the data management initiatives.

The ideal candidate has experience working in a global CRO setting with an excellent understanding of  data management best practices, good clinical practice, and applicable regulatory requirements. This  candidate will have direct experience developing a data management department.

Experience with all  phases of clinical trials, with strong oncology and phase 1 experience, is critical.
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* Job Responsibilities:

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* • Contribute to data management activities in support of clinical studies, including:  o eCRF development by leading cross-functional reviews of eCRF content.  o Database build activities, including review of edit check specifications and performance  of user acceptance testing.  o Monitoring data collection, coding, and cleaning by vendors through tracking of study  metrics and targeted data reviews.  o Oversight of database lock activities and ultimate archiving of study data.

• Collaborate with internal and external partners, including Biostatistics, Statistical Programming,  Clinical Operations, Medical, Quality Assurance, Drug Safety and Pharmacovigilance; CROs,  central and local laboratories, and other vendors.  
• Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and  conduct data reviews.  
• Review CRO data management plans, CRF completion guidelines, edit check specifications,  external data transfer specifications and other study documentation.  
• Represent data management and effectively communicate requirements, strategy, timelines  and deliverables at internal cross-functional team meetings and meetings with external vendors.  
• Participate in the drafting and/or review of timelines consistent with company goals and ensure  all deliverables and milestones are met.  
• Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.  
• Support GCP inspection readiness.  
• Demonstrate clear alignment with company Core Values including, Commitment to People,  Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence.  
• Performs other duties as assigned.  
• May involve travel.  Demonstration of Tempus Compass Values:  Consistently strives to demonstrate the following Highline Sciences values:  
• Recognizes that the team is always stronger than the individual.  
• Seeks to inspire others by demonstrating consistently strong performance.  
• Treats people with respect regardless of role or point of view.  
• Listens well and seek to understand before reacting.  
• Provides candid, helpful, and timely feedback to colleagues.  
• Demonstrates curiosity about and contributes effectively to areas outside of their specialty.  
• Keeps the bigger picture in mind when making decisions.  
• Never stops learning.  
• Questions assumptions and offers suggestions for improvement.  
• Focuses on results rather than process and seeks to minimize complexity when process is required.  
• Identifies and addresses root causes,…