Principal Clinical Investigator Skylimit Research Pvt. Ltd

About Skylimit Research Pvt. Ltd

Job Description

As the Principal Investigator (PI) based in Noida, India, you will play a crucial role in overseeing the scientific, ethical, and regulatory aspects of clinical trials. Your responsibilities will include ensuring participant safety, protocol adherence, and data integrity throughout the trial process. You will collaborate with sponsors, regulatory authorities, and internal teams to achieve successful trial outcomes. Your key responsibilities will involve serving as the lead medical expert for assigned clinical trials, ensuring compliance with ICH-GCP guidelines and local regulatory requirements, overseeing patient recruitment and informed consent processes, documenting and reporting adverse events, participating in protocol development, and providing clinical oversight and training to site staff. To be considered for this role, you must hold an MBBS degree, possess a valid medical license to practice in India, and 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 is essential, along with strong leadership, communication, and analytical skills. Preferred skills for this role include experience in early-phase or late-phase clinical trials, familiarity with electronic data capture systems, and prior participation in audits or regulatory inspections. 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.,