Clinical Operations Manager — Clinical Validation & Medical AI Studies

SAIGroup; Bengaluru; On-site; INR 1,500,000 - 2,000,000; Full time

Benefits offered by this job

Competitive compensation

Leadership growth opportunities

Collaboration with world-class AI researchers

Job summary

A leading medical AI company in Bengaluru is seeking an experienced Clinical Operations Manager. This role involves leading clinical validation studies to ensure that AI systems meet high standards of accuracy and reliability. You will design and oversee clinical studies in collaboration with hospital partners and regulatory bodies, shaping the future of medical AI. Ideal candidates should have 5+ years of clinical operations experience and a strong understanding of regulatory compliance. This position offers competitive compensation and growth opportunities.

Qualifications

• 5+ years experience in clinical operations, clinical research management, or medical device trials.
• Strong understanding of GCP, clinical study protocols, and regulatory compliance.
• Ability to collaborate with clinicians, CROs, investigators, and regulatory bodies.

Responsibilities

• Lead clinical validation studies to ensure AI systems meet clinical standards.
• Manage clinical study planning, execution, and communication with key stakeholders.
• Create comprehensive study reports for regulatory filings and clinical partner communication.

Skills

Project management

Clinical operations

Communication

Stakeholder alignment

Problem-solving

Job description

Clinical Operations Manager — Clinical Validation & Medical AI Studies

About the Role

Our teams are developing breakthrough3D multimodal foundation modelsandagentic medical AI systemsdesigned to assist radiologists and clinicians across diverse workflows.
Your role is to lead theclinical validation studiesthat ensure these systems meet the highest standards ofaccuracy, 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 combineclinical research rigorwithfrontier AI innovation.

What You Will Work On

Clinical Study Planning & Execution

• Develop, manage, and executeclinical validation protocolsfor 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.
• 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 theclinical evidence strategyfor new AI systems capable of multimodal 3D reasoning.
• Your work directly affectsregulatory approval, hospital adoption, and clinician trust.
• You operate at the cutting edge ofmedical 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 inclinical operations, clinical research management, or medical device trials.
• Strong understanding ofGCP, 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.
• Strong 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 defineclinical validation frameworksfor 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.

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