Are you a clinical operations professional with experience supporting IVD, diagnostic, or medical device studies? Ready to help deliver validation studies that advance high-impact diagnostic programs?
Join the SOPHiA GENETICS team as our
Clinical Operations Specialist , and enable us to make a positive impact on the outcomes for cancer and rare disease patients worldwide.
Enjoy the flexibility of a hybrid work schedule allowing 2 days per week home working, collaborating closely with colleagues in our Rolle, CH corporate office.
Our mission We believe there is a smarter, data‑driven way to make decisions in healthcare and our cloud‑native AI powered SOPHiA DDM Platform makes that vision a reality on a daily basis. You will have direct input to our mission to democratize data‑driven medicine for the ultimate benefit of cancer and rare disease patients across the globe.
Your Mission SOPHiA GENETICS is delivering validation studies across IVD and diagnostic programs, including analytical and clinical performance studies. This role sits within a cross‑functional environment, working closely with Clinical Operations, Clinical Affairs, Regulatory Affairs, validation leads, external clinical sites, CROs, and other study partners.
Responsibilities You will support the operational delivery of validation studies, keeping study activities, documentation, ethics submissions, sample logistics, and Trial Master File maintenance moving effectively and on time. This is a hands‑on delivery role for someone who brings strong ownership, follow‑through, and attention to detail in a clinical operations setting.
The value you add
Deliver day‑to‑day operations for IVD and diagnostic validation studies, including analytical and clinical performance studies.
Coordinate external sites, CROs, and internal teams to keep study activities, documentation, and timelines moving.
Manage ethics committee submission materials and follow‑up for studies using clinical samples.
Coordinate clinical sample logistics across study sites, suppliers, and internal stakeholders.
Maintain study documentation and Trial Master File completeness across assigned programs.
Requirements
2 years relevant experience in clinical operations, clinical affairs, study management, or a similar role, working within an IVD, diagnostic, or medical device context.
Working knowledge of IVDR, MDR, Molecular Diagnostics (MDx), Companion Diagnostics (CDx) and NGS‑Assays all highly valuable.
Experience coordinating multi‑site studies, including external site communication and follow‑through.
Hands‑on experience with ethics committee submissions, clinical sample logistics, or Trial Master File maintenance.
Benefits You will be joining an organization with the patient at the heart of every decision and action, driven by purpose as we pursue exponential growth.
Sickness and Accident coverage through Helsana.
Meal vouchers at 90CHF per month with our partner cafeteria.
A fun and engaging work environment, with Rest & Entertainment space, full stocked free coffee machine and free fruit/snacks.
Free parking in an easy to access location.
A strong social committee whose purpose is to make SOPHiA GENETICS both enjoyable and rewarding.
As our global HQ, you’ll have direct interaction and exposure to senior leadership and our executive team locally.
Location & Details Starting Date: ASAP
Location: Rolle, CH
Contract: Permanent
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Join the SOPHiA GENETICS team as our
Clinical Operations Specialist , and enable us to make a positive impact on the outcomes for cancer and rare disease patients worldwide.
Enjoy the flexibility of a hybrid work schedule allowing 2 days per week home working, collaborating closely with colleagues in our Rolle, CH corporate office.
Our mission We believe there is a smarter, data‑driven way to make decisions in healthcare and our cloud‑native AI powered SOPHiA DDM Platform makes that vision a reality on a daily basis. You will have direct input to our mission to democratize data‑driven medicine for the ultimate benefit of cancer and rare disease patients across the globe.
Your Mission SOPHiA GENETICS is delivering validation studies across IVD and diagnostic programs, including analytical and clinical performance studies. This role sits within a cross‑functional environment, working closely with Clinical Operations, Clinical Affairs, Regulatory Affairs, validation leads, external clinical sites, CROs, and other study partners.
Responsibilities You will support the operational delivery of validation studies, keeping study activities, documentation, ethics submissions, sample logistics, and Trial Master File maintenance moving effectively and on time. This is a hands‑on delivery role for someone who brings strong ownership, follow‑through, and attention to detail in a clinical operations setting.
The value you add
Deliver day‑to‑day operations for IVD and diagnostic validation studies, including analytical and clinical performance studies.
Coordinate external sites, CROs, and internal teams to keep study activities, documentation, and timelines moving.
Manage ethics committee submission materials and follow‑up for studies using clinical samples.
Coordinate clinical sample logistics across study sites, suppliers, and internal stakeholders.
Maintain study documentation and Trial Master File completeness across assigned programs.
Requirements
2 years relevant experience in clinical operations, clinical affairs, study management, or a similar role, working within an IVD, diagnostic, or medical device context.
Working knowledge of IVDR, MDR, Molecular Diagnostics (MDx), Companion Diagnostics (CDx) and NGS‑Assays all highly valuable.
Experience coordinating multi‑site studies, including external site communication and follow‑through.
Hands‑on experience with ethics committee submissions, clinical sample logistics, or Trial Master File maintenance.
Benefits You will be joining an organization with the patient at the heart of every decision and action, driven by purpose as we pursue exponential growth.
Sickness and Accident coverage through Helsana.
Meal vouchers at 90CHF per month with our partner cafeteria.
A fun and engaging work environment, with Rest & Entertainment space, full stocked free coffee machine and free fruit/snacks.
Free parking in an easy to access location.
A strong social committee whose purpose is to make SOPHiA GENETICS both enjoyable and rewarding.
As our global HQ, you’ll have direct interaction and exposure to senior leadership and our executive team locally.
Location & Details Starting Date: ASAP
Location: Rolle, CH
Contract: Permanent
#J-18808-Ljbffr
