Principal Clinical Investigator

Role Overview: As the Principal Investigator (PI) based in Noida, India, you will oversee the scientific, ethical, and regulatory aspects of clinical trials. Your crucial responsibilities include ensuring participant safety, protocol adherence, and data integrity throughout the trial process. Collaboration with sponsors, regulatory authorities, and internal teams will be essential to achieve successful trial outcomes. Key Responsibilities: - Serve as the lead medical expert for assigned clinical trials - Ensure compliance with ICH-GCP guidelines and local regulatory requirements - Oversee patient recruitment and informed consent processes - Document and report adverse events - Participate in protocol development - Provide clinical oversight and training to site staff Qualification Required: - Hold an MBBS degree - Possess a valid medical license to practice in India - Have at least 13 years of experience in clinical trials - Prior experience as a Principal Investigator or Sub-Investigator is highly desirable - In-depth knowledge of regulatory frameworks such as ICH-GCP, CDSCO, FDA, and EMA - Strong leadership, communication, and analytical skills Additional Details: It is important to note that only MBBS-qualified doctors who are willing to operate out of Noida should apply for this position. If you are interested in this opportunity, please reach out directly to express your interest and share your updated CV with Elden.mathew@skylimitresearch.com.,