Ing. Mohammed Saleem Farooqi

- Ensure accurate and timely trip report completion and trip report review and the quality of reports are of the highest standards, errors are minimized and that issues are escalated as appropriate - Follow project issue escalation process and Covance Corrective Action Issue Resolution (CAIR) process for clinical operations issues - Ensure site monitoring responsibility for clinical studies are conducted according to Covance

- Perform monitoring visit report review and approval activities under the supervision of the project lead and line manager - Escalate to the project lead any issues and trends noted during the report review process - Performing data analysis by integrating data from various dashboards

- Functioned as the Team Lead and provided project related assistance for assigned complex project(s), sites and study teams - Performed data review, including medical data review, eCRF review, and alert the project managers and data managers of emerging issues - eTMF management, data capture and data transformation as per sponsor requirement

- Performed clinical site monitoring process (Study set-up, Site Selection, Site feasibility, Site initiation, Site interim monitoring and Site close out) in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and medical devices. - Negotiated investigator budgets and assisted with the execution of site contracts with support from the legal department

- Assisted in Recruiting, obtain informed consent, screen and enroll patient research subjects in suitable studies/clinical trials - Collated source data from all relevant sources - Involved in Query resolution and discrepancy management of data, and safety reporting - Assisted the PI in carrying out the protocol related activities

• Basics and application of Programming languages SQL, R, SAS and Python • Analysis of semi- & unstructured data • AI methods such as machine learning • Computational Intelligence: fuzzy logic, neural Networks, Evolutionary Algorithms