Sindhu Mohan Email and Phone Number

•My bachelor’s is in medical science, in addition to a graduate certificate program in Clinical Data Analysis, has provided me with a comprehensive understanding of drug development/medical device as well as the technology, systems and platforms for analysis. I am also highly motivated and passionate about clinical analytics and am ready to commit to this new career path.I bring my past medical experience as a medical officer and research associate. This has given me a strong foundation in the healthcare industry with compliance to HIPPA and IRB, and my passion lies in analytics. This is the reason I am pursuing a career transition into clinical analytics. The job requirements include closely following protocols, carefully analyzing databases, and always ensuring strict quality controlMY skills: Attained strong understanding of human subject protection for clinical trials, ethical and regulatory compliance of US FDA/ICH/GCP regulatory requirements and IRB functions, HIPAA and more.• Proficient in clinical trials contracts, vendor management, Trial Design, Roles and Responsibilities, Clinical Trial Phases, Site Selection, Site Management, Site Initiation to Closeout, Trial Monitoring, Source data Verification (SDV), Standard Operating Procedures (SOPs), Contracts and Budgets, Quality Assurance & Audits, Site master File (SMF) and Trial Master File (TMF).• Organizing, analyzing, and finalizing reports for efficacy and safety for the new development product, along with database management- Oracle Clinical functions, clinical data applications (CTMS tools), attained knowledge in IVRS/ IWRS, Data cleaning, writing queries, review regulatory binders, data verifications using CTMS tool.• Thorough understanding of Biostatistics and the application of healthcare and clinical data through principals of Epidemiology.• Application of Statistical Analytical Software (SAS) in an efficient way to analyze and submit clinical trial and drug safety data.