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Tempus AI · 6 hours ago

Manager, Regulatory Operations

Chicago, IL

Full-time

Hybrid

Mid, Senior Level

$90K/yr - $120K/yr

5+ years exp

Tempus AI is focused on precision medicine and leveraging AI to enhance clinical care. The Manager of Regulatory Operations will oversee study start-up and maintenance, manage relationships with clinical sites, and ensure compliance with regulatory requirements while providing support to the study team.

Artificial Intelligence (AI)BiotechnologyHealth CareMachine LearningMedicalPrecision Medicine

Responsibilities

Efficiently manages and successfully executes all aspects of study start-up and maintenance which includes but is not limited to initial site outreach to begin the CDA process, feasibility, regulatory packet creation and dissemination to selected sites, site outreach involving relationship building and helping to ensure study timelines are met, etc

Supports Sr. Associate as needed with ongoing regular outreach to clinical sites to facilitate essential document collection and other start up and maintenance related activities. Maintains feasibility tracking through site selection, and status tracking in CTMS

Performs study file reviews as assigned per the study specific Trial Master File (TMF) plan

Reviews master informed consent forms (ICF) to ensure compliance with ICH-GCP requirements and completes necessary documentation

Reviews Central IRB or site-adapted ICFs for compliance with protocol elements and ICH-GCP requirements and completes necessary documentation. Provides site-specific ICFs to Sponsor for review as required per study plans

Completes submission of necessary documents to the Central IRB

May support Contract and Budget negotiations with sites and liaising with the sponsor

Reviews pertinent regulations to develop proactive solutions to start-up issues and challenges

Provides regular updates/reports to the study team in preparation for internal and client calls

Presents status updates as necessary in project-related meetings/teleconferences per the study team

Provides oversight for all activities assigned to Associate/Sr. Associate

Maintains close communication with the study team

Works cross-functionally to support RAIS, Clinical Operations, and Project Management departments as necessary

May be responsible for people management activities including interviewing, professional development, performance appraisals, training, and mentorship

Performs other duties as assigned

May involve travel

Qualification

Clinical research experienceStudy start-up experienceWorking knowledge of ICH-GCPCTMS tracking experienceMicrosoft WordExcelTeam orientationPresentation skillsNegotiation skillsDocumentation skillsLeadership skillsInterpersonal skillsWritten communicationOral communicationOrganizational skillsCustomer focus

Required

University/college degree (life science preferred) or certification in a related allied health profession (i.e., nursing) from an appropriately accredited institution

5 or more years of clinical research experience with study start-up experience within a contract research organization or pharmaceutical company

Working knowledge of ICH-GCP

Excellent presentation, negotiation, documentation, and leadership skills, as well as strong team-orientation and interpersonal skills

Excellent written/oral communication and organization skills

Proficient in Microsoft Word and Excel

Customer focus with ability to manage challenging priorities and remain flexible and adaptive in stressful situations

Preferred

Prior experience in team or line management

Experience tracking in a CTMS or online database

Benefits

Incentive compensation

Restricted stock units

Medical and other benefits

Company

Tempus AI

Glassdoor3.0

Tempus is making precision medicine a reality by applying AI in healthcare, deriving insights from our expansive library of clinical data and molecular data.

Founded in 2015

Chicago, Illinois, USA

1001-5000 employees