Job Title / Role: Clinical Imaging & ML Validation Specialist

Key Skills: AI/ML frameworks (TensorFlow, PyTorch) and Medical Imaging

Experience: A minimum of 8 years related experience is required.

Location: Remote

Shift: 8 AM - 5 PM

We at Coforge are seeking seeking a highly skilled professional with expertise in clinical imaging workflows and machine learning (ML) validation within the framework of Good Clinical Practices (GCP). The ideal candidate will bridge the gap between clinical imaging standards and advanced AI/ML technologies, ensuring compliance, accuracy, and reliability of algorithms used in life science.

Key Responsibilities

• Understand and document end-to-end clinical imaging processes (e.g., acquisition, storage, interpretation, and reporting).
• Design and execute validation protocols for ML algorithms applied to imaging data.
• Ensure compliance with GCP, FDA, and other relevant regulatory guidelines during algorithm testing and deployment.
• Perform statistical analysis and benchmarking of algorithm performance against clinical standards.
• Collaborate with radiologists, imaging technicians, and clinical teams to ensure imaging protocols align with regulatory standards.
• Understand different clinical modalities, therapeutics areas and workflows, and Ability to interpret radiology reports and clinical annotations.
• Maintain rigorous documentation for validation activities in accordance with GCP.
• Support audits and regulatory submissions by providing detailed validation reports.
• Work closely with data scientists, software engineers, and clinical teams to integrate validated ML models into clinical workflows.
• Provide domain expertise during product development and risk assessment phases.

Required Qualifications

• Bachelor’s or Master’s degree in Biomedical Engineering, Medical Imaging, Computer Science, or related field.
• Strong understanding of clinical imaging modalities (MRI, CT, X-ray, Ultrasound) and associated workflows.
• Hands-on experience with ML algorithm validation and performance metrics (e.g., sensitivity, specificity, ROC curves).
• Familiarity with Good Clinical Practices (GCP) and regulatory frameworks (FDA, EMA).
• Proficiency in Python/R for data analysis and validation scripting.

Preferred Skills

• Experience with DICOM standards and PACS systems.
• Knowledge of AI/ML frameworks (TensorFlow, PyTorch) and medical imaging libraries (e.g., MONAI).
• Prior experience in clinical trials or regulated healthcare environments.

Soft Skills

• Strong analytical and problem-solving abilities.
• Excellent communication and documentation skills.
• Ability to work in cross-functional teams and manage multiple priorities.

Contact information:

Looking forward to receiving your profile, for more details please email at [email protected]