Principal Investigator

Role Overview: As the Principal Investigator for Early Phase Trials in the Discovery Services department, your primary responsibility is to review RFX and feasibility, provide crucial insights, anticipate risks, and offer solutions. Collaboration with various departments such as PMO, Bio-analytical, Statistical, Finance, Regulatory, Central Lab, Legal, and Administration is essential to develop and execute projects effectively. Key Responsibilities: - Ensure the rights and welfare of research subjects by obtaining informed consent and conducting research in compliance with Good Clinical Practice and ethical principles. - Supervise the research process, provide necessary resources, staff, and facilities, and maintain a thorough knowledge of investigational medicinal products and protocols. - Evaluate adverse events, make medical decisions, supervise the Trial Master file, provide protocol training, and facilitate document access for audits. - Liaise with Ethics Committees, regulatory authorities, and sponsors to ensure compliance with regulatory requirements and timely reporting. - Identify training needs, review SOPs/IOPs, manage investigational product accountability, follow randomization procedures, and review/approve Clinical Study Reports. - Collaborate with the Quality Assurance Department for audits and inspections to maintain data integrity and accuracy. Qualification Required: - Demonstrate Syngene's core values of Excellence, Professionalism, Integrity, and Customer Centricity. - Possess effective communication, interpersonal skills, team and time management, and a proactive attitude. - Commitment to safety, continuous improvement, and alignment with company goals through coaching and corrective practices.,