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.