1. To develop a working knowledge of Clinical Study Protocol (CSP), Data Handling Plan (DHP) and Data Review Plan (DRP)2. Participating in DM activities for start-up of a trial which includes protocol review, Case Report Forms (CRF)/electronic Case Report Forms (eCRF) design and performing User Acceptance Testing (UAT) if required.3. Provides input to writing specifications for study specific validation checks and necessary reports to ensure high quality and consistent data.4. Participates in ongoing review of all data generated from the clinical study including central and local lab data as well as coding.5. Participates in the preparation of final study documentation

•Perform QC testing and follow UAT procedures for conformance and specs•Coordinate UAT related efforts within the dept. and across different functional areas for specific studies•Review study specific design specs •Modify Standard test plan templates and study specific test scripts •Perform execution of standard and trial specific test scripts•Record data and test results•Report and document test results for individual studies

•Working as Associate in SAS listings projects.•Understanding basic database structure, SAS listing output structural review, SAS variable and code used for programming and performing listing manual review along with testing of Clinical Data Base.•Understanding requirement of protocol, SAS listings specification, CRF and Non-CRF entry guidelines, Data cleaning plan and data management plan to assist data team lead in developing all documents by reviewing them as per the study timeline •Test case creation for SAS listing checks, entry of test data in database and validation. Validation includes review of data in the SAS output in the form of ADMS and Non-ADMS as per the listing requirement for the purpose of data cleaning in accordance with protocol.•Worked on all kind of SAS listings checks including eCRF listings, Lab data reconciliation listings, SAE reconciliation listing, Medical review listing and Medical coding listings. •Project communication among study team members during different stages of study related to deliverable of each activity as per projected timeline.•Quality Review of activities done by team member •Maintain Documentation after completion each activities as per the SOP/WI•Timely reporting of work status to higher level management to ensure that for any complex issues RCA is done and CAPA is implemented effectively.•To assist with the training. •Perform other project activities as required in order to ensure that study timelines are met by maintaining productivity and quality matrices and trackers.