Note: The job is a remote job and is open to candidates in USA. Tempus AI develops a proprietary precision medicine platform that connects real-world evidence to provide actionable insights for clinical care. The Lead Clinical Data Manager will lead data management activities for client studies across all stages of clinical drug development, collaborating with cross-functional teams, CROs, and vendors while overseeing data quality, database builds, reviews, transfers, and lock activities.
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
- 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
Skills
- 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
- 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
- MS or equivalent preferred
- 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
Benefits
- Incentive compensation, depending on the position
- Restricted stock units, depending on the position
- Medical benefits, depending on the position
Company Overview
Company H1B Sponsorship