Paulraj Shanmugam

* Develop, Validate & Maintain standard SAS programs for End-point Adjudication process in Clinical Trials * Creating Reports and Validating from QC side

* Created SDTM Annotations Based on the sponsor standards as well CDISC SDTM guidelines. * Created SDTM Mapping specification Based on the Annotated CRF. * Worked on SDTM programming for multiple studies and developed CDISC compliant SDTM transfer datasets. * Thoroughly understand trial related documents such as protocol, aCRF, Specification and SOPs Created standard SDTM compliant datasets using SDTM Mapping Specification. * Created SUPPLIMENTARY (SUPP) datasets and Relation (RELREC) Datasets.