Clinical Data Manager
Tempus AI
Summary
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.
Job description
Job Responsibilities
- 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.
- May involve travel.
Minimum Qualifications
- BS/BA in scientific discipline, MS or equivalent preferred, with at least 8 years related experience in a CRO/pharmaceutical/biologics/biotechnology company.
- Study/Vendor oversight experience.
- Experience with global studies, utilizing an outsourced CRO model.
- 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.
Preferred Qualifications
- Experience working with Medidata Rave EDC.
- Experience using standardized medical terminology, including MedDRA and WHODrug.
- Prior experience working for both a Sponsor company and a CRO.
- Early phase clinical trial experience.
Personal Skills
- 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.
Requirements
- BS/BA in scientific discipline
- MS or equivalent preferred
- At least 8 years related experience in a CRO/pharmaceutical/biologics/biotechnology company
- Study/Vendor oversight experience
- Experience with global studies, utilizing an outsourced CRO model
- 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
- Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
- Highly motivated and flexible
- 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 working with Medidata Rave EDC
- Experience using standardized medical terminology, including MedDRA and WHODrug
- Prior experience working for both a Sponsor company and a CRO
- Early phase clinical trial experience
- Excellent interpersonal and communications 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
- 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
- Excellent presentation skills: internal, external
Benefits
- Incentive compensation
- Restricted stock units
- Medical benefits
Company overview
Tempus AI, Inc. (NASDAQ: TEM) is a pioneering healthcare technology company founded in 2015 by Eric Lefkofsky in Chicago, Illinois. The company was established after Lefkofsky's wife was diagnosed with breast cancer, driving his mission to revolutionize cancer care through technology and artificial intelligence. Tempus specializes in applying AI to advance precision medicine by collecting and analyzing vast amounts of molecular, clinical, and genomic data. The company operates across multiple therapeutic areas including oncology, cardiology, radiology, neurology, psychiatry, and dermatology. Tempus provides comprehensive diagnostic services including next-generation sequencing (NGS), PCR profiling, and molecular pathology testing. Its AI-powered platform enables physicians to make real-time, data-driven decisions for personalized patient care and targeted therapies. The company went public in June 2024 and has expanded globally with operations in multiple countries. Tempus continues to innovate at the intersection of healthcare and artificial intelligence, aiming to ensure patients receive the right treatments at the right time for improved health outcomes.