About the Role
Our teams are developing breakthrough
3D multimodal foundation models
and
agentic medical AI systems
designed to assist radiologists and clinicians across diverse workflows.
Your role is to lead the
clinical validation studies
that ensure these systems meet the highest standards of
accuracy, safety, reliability, and clinical utility
.
You will design, coordinate, and oversee retrospective and prospective clinical studies in collaboration with hospital partners, radiology groups, CROs, and internal research teams. Your work directly determines how our AI systems are trusted and adopted in clinical environments.
This is a pivotal role for someone who wants to combine
clinical research rigor
with
frontier AI innovation
.
What You Will Work On
Clinical Study Planning & Execution
Develop, manage, and execute
clinical validation protocols
for 3D AI models and agentic medical systems.
Lead retrospective, prospective, observational, and workflow-integration studies.
Define clinical endpoints, evaluation criteria, inclusion/exclusion criteria, and ground truth generation methodologies.
Coordinate IRB/IEC submissions, ethics approvals, and regulatory documentation.
Site & Investigator Management
Identify, onboard, and manage clinical sites (hospitals, imaging centers, academic partners).
Train site investigators, radiologists, and clinical staff in study procedures and data collection workflows.
Maintain strong, trust-based relationships with clinicians and site coordinators.
Data Quality, Compliance, and Safety
Oversee secure, compliant collection of medical imaging and text data (DICOM, reports, annotations).




Ensure adherence to local and international clinical research regulations (ICMR, GCP, HIPAA-equivalent, MDR).
Lead safety monitoring, data audits, and deviation management.
Cross-Functional Collaboration
Work closely with AI researchers, product managers, and regulatory specialists to align study designs with model capabilities and regulatory requirements.
Provide clinical insights that shape model evaluation metrics, dataset selection, and product features.
Manage communication of progress, risks, and results across engineering, research, and executive teams.
Reporting & Evidence Generation
Create comprehensive study reports for regulatory filings, publications, whitepapers, and clinical partner communication.
Lead statistical analysis planning and coordinate with biostatisticians for rigorous interpretation of study results.
Present clinical findings internally and externally at conferences, workshops, and partner meetings.
Why This Role Is High-Impact
You define the
clinical evidence strategy
for new AI systems capable of multimodal 3D reasoning.
Your work directly affects
regulatory approval
, hospital adoption, and clinician trust.
You operate at the cutting edge of
medical AI validation
, where standard frameworks are still emerging.
You collaborate with top radiologists, hospitals,



and AI researchers to shape the future of clinical AI.
What We're Looking For
5+ years experience in
clinical operations
, clinical research management, or medical device trials.
Strong understanding of
GCP
, clinical study protocols, regulatory compliance, and ethics board processes.
Experience managing imaging-centric or medical device studies (radiology preferred).
Ability to collaborate with clinicians, CROs, investigators, and regulatory bodies.
Excellent project management skills: planning, documentation, risk management, and execution.
Solid communication, stakeholder alignment, and problem-solving abilities.
Passion for improving patient outcomes using next-generation AI technologies.
Nice to Have
Experience with AI/ML-based medical device evaluations (SaMD).
Background in radiology, clinical imaging workflows, or 3D data interpretation.
Familiarity with FDA/EMA/ICMR/NDHM guidelines for AI medical systems.
Prior experience generating or managing ground truth annotation workflows.
Exposure to biostatistics, ROC/AUC analysis, reader studies, and multi-reader multi-case (MRMC) study design.
What We Offer
Competitive compensation and leadership growth opportunities.
Chance to define
clinical validation frameworks
for the next major class of medical AI systems.
Collaboration with world-class AI researchers, clinicians, and medical institutions.
Autonomy to design studies, build site networks, and shape evidence strategy from the ground up.
Mission-driven culture focused on trust, clinical excellence, and patient impact.

📌 Clinical Operations Manager Clinical Validation & Medical Ai Studies (Bengaluru)
🏢 SAIGroup
📍 Bengaluru