About Kozhnosys: Kozhnosys is a healthcare innovation startup pioneering non-invasive cancer diagnostics through exhaled breath analysis. As we expand our operations nationally, we are seeking a Clinical Trial Manager to lead the execution of our clinical studies with scientific rigor and operational excellence. Role Summary: The Clinical Trial Manager (CTM) will oversee the planning, execution, and reporting of clinical trials for Kozhnosys’ diagnostic technologies. This role requires a strategic thinker with hands-on experience in clinical operations, regulatory compliance, and cross-functional coordination. The CTM will ensure that trials are conducted in accordance with ICH-GCP, local regulations, and internal SOPs, while maintaining the highest standards of data integrity and patient safety. Key Responsibilities: Design and manage prospective and retrospective diagnostic studies. Develop clinical trial protocols, case report forms (CRFs), informed consent documents, and study manuals. Coordinate with principal investigators, CROs, and regulatory bodies to ensure timely approvals and site readiness. Oversee site selection, initiation, monitoring, and close-out activities. Travel to different site locations across India and monitor progress and compliance. Ensure compliance with ethical standards, GCP, and regulatory requirements in India, and other jurisdictions. Lead cross-functional teams including data management, biostatistics, and QA to ensure trial milestones are met. Monitor trial progress, manage risks, and implement corrective actions as needed. Prepare clinical performance evaluation reports, including sensitivity, specificity, and ROC analysis. Present trial updates to internal stakeholders, investors, and regulatory authorities. Prepare manuscripts based on study results in international journal. Apply for government grants and other funding opportunities for conducting clinical trials. Represent company in medical conferences and present the trial data. Manage team of clinical trial coordinators at different study centers. Qualifications: Master’s degree or higher in Life Sciences, Pharmacy, or related field. Minimum 5 years of experience in clinical trial management, preferably in diagnostics or medical devices. Strong knowledge of ICH-GCP, ISO 14155, and regulatory frameworks in India, Europe and North America. Experience with observational study designs and diagnostic accuracy studies. Excellent communication and stakeholder management skills. Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS). Preferred: Experience with breath-based diagnostics or sensor-based medical technologies. Certification from ACRP or SOCRA. Prior involvement in early-stage startup environments.

Location: Mangalore/Rishikesh/Pune Employment Type: Contract About the Role We are seeking an experienced Biomedical Engineer to oversee hospital-based clinical trials for CanScan. The trial sites are Mangalore and Rishikesh. There are 2 openings, 1 in Mangalore and 1 in Rishikesh. The candidate should be willing to stay in Mangalore or Rishikesh till the completion of the trial with occasional travel to Pune for reporting. The role involves hands-on medical equipment operation, trouble shooting, servicing, inventory & logistics of consumables and maintenance of the device for the successful trial completion. The person should ensure seamless trial execution, regulatory compliance, and high-quality reporting. The ideal candidate will collaborate closely with principal investigators (PIs), research assistants, and hospital staff to drive research success. Key Responsibilities Medical Equipment Handling : Oversee the setup, calibration, maintenance, troubleshooting of CanScan and consumables and accessories in hospital settings. Operation: Assist in monitoring CanScan’s sensor performance, calibration, and patient interaction during trials. Clinical Trial Monitoring: Ensure protocol compliance, data accuracy, and efficient trial execution, identifying and mitigating potential risks. Report Writing & Documentation: Draft detailed trial reports , capturing equipment performance, patient responses, and key clinical insights. Stakeholder Coordination: Engage with PIs, research assistants, and hospital administrators to ensure alignment on trial procedures and findings. Regulatory & Compliance Management: Ensure adherence to GCP standards, hospital ethics approvals, and device-related regulatory frameworks . Overall Trial Management: Maintain documentation, oversee equipment logistics, and support trial teams in day-to-day operations. Qualifications & Requirements Degree in Biomedical Engineering or related field . Hands-on experience with ventilators, CPAP, BiPAP, and other medical devices. Familiarity with medical device handling and operation required. Prior involvement in clinical trials, hospital-based research, or medical equipment validation . Strong knowledge of clinical trial protocol development, statistical analysis, and reporting . Excellent communication and organizational skills to collaborate with medical and research teams. Knowledge of ICMR, FDA, or other relevant regulatory frameworks is highly beneficial.

As a Biomedical Engineer working on hospital-based clinical trials for CanScan, you will play a crucial role in ensuring the successful completion of trials at our sites in Mangalore and Rishikesh. You will be responsible for overseeing the operation, maintenance, and troubleshooting of medical equipment, as well as managing inventory and logistics of consumables. Your dedication to regulatory compliance, seamless trial execution, and high-quality reporting will be essential for the success of the research. Your key responsibilities will include handling medical equipment setup, calibration, and maintenance in hospital settings, monitoring CanScan sensor performance during trials, ensuring protocol compliance and data accuracy, drafting detailed trial reports, and coordinating with stakeholders such as principal investigators and hospital staff. Your role will also involve maintaining documentation, managing equipment logistics, and supporting day-to-day trial operations. To excel in this position, you should hold a degree in Biomedical Engineering or a related field and have hands-on experience with medical devices like ventilators, CPAP, and BiPAP. Prior involvement in clinical trials or hospital-based research, along with strong knowledge of clinical trial protocols, statistical analysis, and reporting, will be beneficial. Effective communication and organizational skills are essential for collaborating with medical and research teams, and familiarity with regulatory frameworks such as GCP standards, ICMR, and FDA regulations will be highly advantageous. If you are ready to take on this challenging yet rewarding role, where you will contribute to groundbreaking research and work closely with a dedicated team of professionals, we invite you to apply and be a part of our innovative journey in healthcare.,

Location: Mangalore/Rishikesh/Bhopal/Pune Multiple Openings Salary: 4-5LPA Experience:1-2 years as biomedical engineer in hospital Male candidates preferred About the Role We are seeking an experienced Biomedical Engineer to oversee hospital-based clinical trials for CanScan. The trial sites are Mangalore and Rishikesh. There are 2 openings, 1 in Mangalore, 1 in Bhopal and 1 in Rishikesh. The candidate should be willing to stay in Mangalore or Rishikesh till the completion of the trial with occasional travel to Pune for reporting. The role involves hands-on medical equipment operation, trouble shooting, servicing, inventory & logistics of consumables and maintenance of the device for the successful trial completion. The person should ensure seamless trial execution, regulatory compliance, and high-quality reporting. The ideal candidate will collaborate closely with principal investigators (PIs), research assistants, and hospital staff to drive research success. Key Responsibilities Medical Equipment Handling : Oversee the setup, calibration, maintenance, troubleshooting of CanScan and consumables and accessories in hospital settings. Operation: Assist in monitoring CanScan’s sensor performance, calibration, and patient interaction during trials. Clinical Trial Monitoring: Ensure protocol compliance, data accuracy, and efficient trial execution, identifying and mitigating potential risks. Report Writing & Documentation: Draft detailed trial reports , capturing equipment performance, patient responses, and key clinical insights. Stakeholder Coordination: Engage with PIs, research assistants, and hospital administrators to ensure alignment on trial procedures and findings. Regulatory & Compliance Management: Ensure adherence to GCP standards, hospital ethics approvals, and device-related regulatory frameworks . Overall Trial Management: Maintain documentation, oversee equipment logistics, and support trial teams in day-to-day operations. Qualifications & Requirements Degree in Biomedical Engineering or related field . Hands-on experience with ventilators, CPAP, BiPAP, and other medical devices. Familiarity with medical device handling and operation required. Prior involvement in clinical trials, hospital-based research, or medical equipment validation . Strong knowledge of clinical trial protocol development, statistical analysis, and reporting . Excellent communication and organizational skills to collaborate with medical and research teams. Knowledge of ICMR, FDA, or other relevant regulatory frameworks is highly beneficial.

Job description Location: Mangalore/Rishikesh/Bhopal Multiple openings CTC: Rs 4-5 lakhs About the Role We are seeking an experienced Engineer s to oversee hospital-based clinical trials for CanScan. The trial sites are Mangalore, Bhopal and Rishikesh. There are 3 openings, 1 in Mangalore, 1 in Bhopal and 1 in Rishikesh. The candidate should be willing to stay in Mangalore, Bhopal or Rishikesh till the completion of the trial with occasional travel to Pune for reporting. The role involves hands-on medical equipment operation, trouble shooting, servicing, inventory & logistics of consumables and maintenance of the device for the successful trial completion. The person should ensure seamless trial execution, regulatory compliance, and high-quality reporting. The ideal candidate will collaborate closely with principal investigators (PIs), research assistants, and hospital staff to drive research success. Key Responsibilities Medical Equipment Handling : Oversee the setup, calibration, maintenance, troubleshooting of CanScan and consumables and accessories in hospital settings. Operation: Assist in monitoring CanScan’s sensor performance, calibration, and patient interaction during trials. Clinical Trial Monitoring: Ensure protocol compliance, data accuracy, and efficient trial execution, identifying and mitigating potential risks. Report Writing & Documentation: Draft detailed trial reports , capturing equipment performance, patient responses, and key clinical insights. Stakeholder Coordination: Engage with PIs, research assistants, and hospital administrators to ensure alignment on trial procedures and findings. Regulatory & Compliance Management: Ensure adherence to GCP standards, hospital ethics approvals, and device-related regulatory frameworks . Overall Trial Management: Maintain documentation, oversee equipment logistics, and support trial teams in day-to-day operations. Qualifications & Requirements Degree in Biomedical/Electronics/Mechanical Engineering . Familiarity with medical device handling and operation required. Prior involvement in medical equipment validation . Excellent communication and organizational skills to collaborate with medical and research teams.