Connection profile

manasasomireddy115

About: Clinical Research Professional with 3.8 years of total experience, including 2.8 years in clinical research under SMO (Kairos R&D Solutions Pvt. Ltd.) at NIMS site and 1 year in pharmaceutical analysis. Experienced in end-to-end clinical trial execution from study startup to closeout, including participant screening and enrollment, informed consent, source documentation, SDV/SDR support, protocol deviation tracking, regulatory documentation, TMF/eTMF and ISF maintenance, EDC data entry, query management, investigational product accountability, monitoring visit coordination, and study finance activities. Skilled in TMF reconciliation, QC support, audit and inspection readiness, with strong knowledge of ICH-GCP, ALCOA+, and protocol compliance. Proficient in EDC and IWRS/IRT systems, ensuring data integrity, regulatory compliance, and patient safety throughout the clinical trial lifecycle