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.
The 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 for Tempus Compass.
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.
- Contribute to data management activities in support of clinical studies, including:
- eCRF development by leading cross-functional reviews of eCRF content
- Database build activities, including review of edit check specifications and performance
of user acceptance testing
- Monitoring data collection, coding, and cleaning by vendors through tracking of study
metrics and targeted data reviews
- 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
- BS/BA in scientific discipline, MS or equivalent preferred, with at least 7 years 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
- Proficient in Microsoft Word and Excel
- Experience with global studies, utilizing an outsourced CRO model
- Experience working with Medidata Rave EDC
- Experience using standardized medical terminology, including MedDRA and WHODrug
- Excellent interpersonal and communications skills (verbal and written), as well as problem solving
and organization skills
- Proven ability to work independently
- Self-motivated, pro-active, and resourceful
- Strong ability to manage managers and/or individual contributors
- Outstanding organizational skills
- Excellent analytical and problem-solving skills
- Excellent communication skills with a diplomatic approach including the ability to work with various personalities and perspectives
- Excellent 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 development
- Excellent presentation skills: internal, external
About Tempus Compass:
- We actively strive to differentiate ourselves to both employees and clients with our unique culture that has been created very intentionally with much care and effort.
- Our core belief is that it’s all about the team. More specifically, bringing great people together to deliver incredible outcomes. With this approach, we are a more flexible, collaborative, innovative, inspiring and successful organization. We also happen to 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 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
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.