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/biologics/biotechnology company

• Study/vendor oversight experience

• Expert knowledge of data management processes, efficient design/build of an EDC data management system, and other Clinical Trial/Data Management Systems

• Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH

• Experience working with EDC data management systems

• Understanding of ICH GCP as well as general knowledge of industry practices and standards

• Knowledge and understanding of regulatory requirements and expectations for clinical data systems, including 21 CFR Part 11

• Highly motivated and flexible, with excellent organizational and time management skills

• Ability to work independently and as part of a multi-disciplinary team

• Proficiency in Microsoft Word and Excel
   

Preferred Qualifications

• Experience with global studies utilizing an outsourced CRO model

• Experience working with Medidata Rave EDC

• Experience using standardized medical terminology, including MedDRA and WHODrug
   

Personal Skills

• Excellent interpersonal and communication skills (verbal and written), as well as problem-solving and organizational skills

• Proven ability to work independently

• Self-motivated, proactive, and resourceful

• Strong ability to manage managers and/or individual contributors

• Outstanding organizational skills

• Excellent analytical and problem-solving abilities

• Excellent communication skills with a diplomatic approach, including the ability to work with various personalities and perspectives

• Strong ability to lead cross-functional initiatives related to Data Management

• 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

• Excellent internal and external presentation skills
   

About Tempus Compass
Tempus Compass actively strives to differentiate itself to both employees and clients with a unique culture created intentionally with care and effort.

Our core belief is that it’s all about the team—bringing great people together to deliver incredible outcomes. With this approach, we are a more flexible, collaborative, innovative, inspiring, and successful organization. We also have a lot of fun!

We believe in questioning the norm and looking for alternatives. We seek out team members who are driven by curiosity and who understand the power of the collective. We encourage continual learning and constructive feedback. We strive to build and maintain trust, both internally and externally.

We provide a supportive, open culture and empower every team member to speak up, voice questions, offer solutions, and actively contribute to the overall success of the company and our clients. We trust team members to take responsibility for demonstrating the highest standards in their personal actions and relationships and holding one another accountable.

Illinois Pay Range: $100,000-$130,000

New York and California Pay Range: ​$9100,000-$130,000

The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

Additionally, for remote roles open to individuals in unincorporated Los Angeles – including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.