Lead Clinical Data Manager

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.

Summary
The Lead Clinical Data Manager contributes to and leads data management activities in support of client studies across all stages of clinical drug development. They are responsible for working with cross-functional teams and leading 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 has direct experience developing a data management department. Experience with all phases of clinical trials, with strong oncology and phase 1 experience, is critical.

Job Responsibilities
 

The Lead Clinical Data Manager:

• Contributes to data management activities in support of clinical studies, including:

  • Leads cross-functional reviews of eCRF content for eCRF development

  • Oversees database build activities, including review of edit check specifications and performance of user acceptance testing

  • Monitors data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews

  • Oversees database lock activities and final archiving of study data

• Collaborates 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

• Establishes cross-functional internal data review plans, coordinates data cuts/transfers, and conducts data reviews

• Reviews CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications, and other study documentation

• Represents data management and communicates requirements, strategy, timelines, and deliverables at internal cross-functional team meetings and meetings with external vendors

• Participates in drafting and/or reviewing timelines consistent with company goals and ensures all deliverables and milestones are met

• Reviews clinical protocols/amendments, clinical study reports, statistical analysis plans, and related documents

• Supports GCP inspection readiness

• Demonstrates 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

• Travels as needed
   

Demonstration of Compass Values
The Lead Clinical Data Manager consistently:

• Recognizes that the team is 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 seeks to understand before reacting

• Provides candid, helpful, and timely feedback to colleagues

• Demonstrates curiosity about and contributes effectively to areas outside 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 minimizes complexity when process is required

• Identifies and addresses root causes, not symptoms

• Demonstrates poise in stressful situations

• Strives to always do the right thing

• Questions actions that are incongruent with Tempus Compass values

Minimum Qualifications

• BS/BA in a scientific discipline; MS or equivalent preferred, with at least 5 years of related experience in a CRO/pharmaceutical/biol