Clinical Trial Manager

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.