Clinical Data Manager

Tempus AI•Remote - Illinois, IL

About The Position

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 Lead Clinical Data Manager will contribute to 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.

Requirements

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.

Nice To Haves

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 (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.

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.