Clinical Study Manager at Tempus

Chicago, Illinois, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Precision Medicine, Clinical ResearchIndustries

Requirements

University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
Minimum of five+ (5) years relevant clinical research experience in a combination of research site, life sciences company or CRO
Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
Demonstrated ability to be self-directed
Working knowledge of project finance
Familiar with concepts commonly incorporated non-therapeutic studies: risk-based monitoring (inferred from context)

Responsibilities

Responsible for executing Tempus’s observational trials in compliance with quality standards (ICH/GCP, Global Regulations, and Tempus policies and procedures)
Act as primary point of contact for clients. Anticipate client needs and proactively resolve issues as necessary
Lead cross-functional teams and third parties/vendors to ensure effective teamwork and communication
Manage project deliverables including timeline, quality, scope, and cost
Maintain study management system(s)
Develop and maintain project plans
Primary contact for assigned sites and build positive relationships with investigators and site staff
Complete monitoring visits and/or oversee Clinical Research Associates, as applicable
Manage participant recruitment, sample reconciliation, data entry to safe-guard project endpoints
Responsible for the completeness and quality of the Trial Master File
Provide temporary coverage/back-up for additional observational studies as required
May involve overnight travel
Demonstrate Tempus Compass Values (e.g., team focus, inspiration, respect, listening, feedback, curiosity, big-picture thinking, continuous learning, questioning assumptions, results-oriented, root cause analysis, poise, integrity)

Skills

Key technologies and capabilities for this role

ICH/GCPClinical MonitoringSite ManagementProject ManagementStudy Management SystemsRisk MitigationVendor ManagementRegulatory ComplianceSOPsCross-Functional Team Leadership

Questions & Answers

Common questions about this position

What are the main responsibilities of the Clinical Study Manager?

The role involves independently planning, executing, monitoring, and closing observational/non-interventional studies, directing financial and operational aspects, acting as the primary liaison to clients, project teams, and vendors, and ensuring delivery within budgets and timelines while complying with regulations and Tempus SOPs.

Is travel required for this position?

Yes, the role may involve overnight travel.

What are the Tempus Compass Values that employees should demonstrate?

Employees should demonstrate values such as recognizing the team is stronger than the individual, inspiring others with strong performance, treating people with respect, listening well, providing candid feedback, showing curiosity, keeping the bigger picture in mind, never stopping learning, questioning assumptions, and focusing on results.

What skills or experiences make a strong candidate for this role?

Strong candidates will have experience leading cross-functional teams and vendors, managing project deliverables like timelines, quality, scope, and cost, conducting monitoring visits or overseeing Clinical Research Associates, and ensuring compliance with ICH/GCP and regulations, along with proactive risk mitigation and client management.

What is the salary or compensation for this position?

This information is not specified in the job description.

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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