Manager, Regulatory Operations at Tempus

Chicago, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Precision Medicine, Clinical TrialsIndustries

Requirements

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

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
Consistently strives to demonstrate the Tempus Compass values (e.g., team stronger than individual, inspires others, treats people with respect, listens well, provides feedback, demonstrates curiosity, keeps bigger picture in mind, never stops learning, questions assumptions, focuses on results, addresses root causes, demonstrates poise, strives to do the right thing)

Skills

Key technologies and capabilities for this role

ICH-GCPCTMSTMFIRBICFCDAFeasibility TrackingRegulatory PacketSite OutreachContract Negotiation

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time role.

Is remote work allowed or is there an office requirement?

This information is not specified in the job description.

What key skills or experiences are required for this role?

The role requires experience in study start-up and maintenance, regulatory compliance including ICH-GCP and IRB submissions, relationship building with clinical sites, and proficiency with CTMS and TMF systems.

What are the Tempus Compass values I should demonstrate?

Tempus Compass values include recognizing that the team is stronger than the individual, inspiring others through strong performance, treating people with respect, listening well, providing candid feedback, demonstrating curiosity, and keeping the bigger picture in mind.

What makes a strong candidate for this Manager role?

Strong candidates have regulatory operations experience in clinical studies, can manage teams including interviewing and mentorship, and demonstrate Tempus Compass values like teamwork and curiosity.

Tempus

AI-driven healthcare data analysis platform

About Tempus

Tempus focuses on enhancing patient outcomes through the use of data and artificial intelligence in healthcare. The company offers a platform that analyzes medical data to provide insights for physicians, helping them make better treatment decisions. This platform also aids pharmaceutical and biotech companies in drug development by identifying new targets and assessing treatment effectiveness. For patients, Tempus identifies personalized therapy options, particularly in cancer care, where their research has shown increased opportunities for tailored treatments. They have developed a pan-cancer organoid platform and a liquid biopsy assay for profiling circulating tumor DNA. Tempus generates revenue by charging healthcare providers and companies for access to their platform and insights, setting them apart from competitors by their focus on personalized medicine and extensive cancer research.

Chicago, IllinoisHeadquarters

2015Year Founded

$894.9MTotal Funding

IPOCompany Stage

AI & Machine Learning, Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Relocation Assistance

Company Equity

Performance Bonus

Risks

Competition from partners like Genialis may lead to conflicts of interest.

Ambry Genetics acquisition could pose financial risks if synergies aren't realized.

Technical challenges may arise in integration with Flatiron's OncoEMR platform.

Differentiation

Tempus uses AI to analyze clinical and molecular data for precision medicine.

Their platform aids in personalized treatment decisions for cancer patients.

Tempus collaborates with biotech firms to enhance drug development using real-world data.

Upsides

Increased AI adoption in healthcare boosts Tempus' partnerships and collaborations.

Acquisition of Ambry Genetics expands Tempus' genetic testing capabilities.

Integration with Flatiron's OncoEMR enhances precision in cancer treatment plans.

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