Harsha Haridas Email & Phone Number

With several years of experience in this field, I have gained expertise in coordinating and supporting various aspects of clinical trials, including project management, documentation, and compliance. Throughout my career, I have successfully worked with Clinical Trial Management Systems (CTMS) to track and monitor trial progress, ensuring adherence to timelines and milestones. Additionally, I am proficient in Veeva Vault, Medidata, ePIP, Lab portals, RQCMS, Signant Health IRT and Signant Health Trial Manager leveraging these platforms to streamline trial documentation, data management, and collaboration. My experience includes effectively coordinating and maintaining trial-related documentation, such as study protocols, informed consent forms, and regulatory submissions, using these platforms. Furthermore, I have a comprehensive understanding of regulatory guidelines, such as Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines, which enables me to ensure compliance throughout the entire clinical trial process. I am highly organized, detail-oriented, and possess excellent communication and problem-solving skills. I thrive in fast-paced environments and enjoy collaborating with multidisciplinary teams to achieve project goals and deliver high-quality results.

Listed skills include Clinical Data Management, Analytical Skills, Regulatory Affairs, Clinical Trial Conduct And Operations, and 3 others.