Global Companion Diagnostics Manager - Hybrid

Caris Life Sciences•Papago, AZ

2d•$125,000 - $145,000•Hybrid

About The Position

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare—driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins. Position Summary The Global Companion Diagnostics Manager is a key contributor in the Translational Science team responsible for leading companion diagnostic and in vitro diagnostic product development lifecycle programs to support global marketing authorizations. This includes clinical programs with focused attention on Design Controls and Good Clinical Practices for clinical performance studies. The Global Companion Diagnostics Manager will collaborate with Biopharma Partnering, Clinical Research, QA, Regulatory Affairs and other study stakeholders to lead and coordinate study-related activities that are tailored to specific program requirements. Additional responsibilities include creating study-specific and departmental documentation including but not limited to SOPs, templates, forms, plans, protocols and reports through close collaboration with the appropriate cross-functional teams. The Global Companion Diagnostics Manager will support clinical study compliance through creation and maintenance of trial master files, study tracking as well as leading meetings with the study personnel.

Requirements

Minimum of BS Degree in a scientific discipline with 7 years experience or MS with 5 years experience in IVD clinical studies.
Broad knowledge of key CDx deliverables including IUO clinical trial assays, sample management, data transfer/delivery, external partners, co-development bridging studies.
Understanding of Good Clinical Practices (GCP) and other relevant regulatory requirements.
Scientific writing experience (e.g., peer-reviewed publications, clinical study protocols and reports, SOPs, etc.).
Must be tolerant to change, ready to take on new challenges and open to learning in a dynamic environment.

Nice To Haves

Knowledge of Next Generation Sequencing.
Design for Six Sigma and/or other process methodology tools training.
Certification as a Clinical Research Professional.

Responsibilities

Lead IVD/CDx clinical programs.
Contribute to cross-functional strategy and program planning scenarios.
Proactively identify, track, manage and resolve clinical program risks and issues.
Clinical study representative for project and study teams.
Facilitate internal and external clinical study preparation and planning meetings.
Collaborate and communicate with study personnel and stakeholders.
Ensure study protocol, GCP, regulatory and SOP compliance.
Participate in clinical site assessment, selection, qualification, initiation and closeout processes.
Provide clinical study site oversight.
Create and maintain study-specific and trial master files.
Contribute to and/or lead process improvements.
Socialize regulatory requirements and standards (e.g., FDA, ICH GCP, ISO 20916, IVDR, MDCG) with cross-functional teams and study personnel.
Accepts other duties as assigned.