SACHIN DATANIYA

· Good programming skills in SAS (Base and Advance) technologies.

· Good programming skills in Clinical R Programming.

Programming of external validation checks and execute the same as requested by study team using SAS and R Programming.

· Knowledge of Generated Tables and Listings as per the SAP by using Raw data and aCRF using SAS and R Programming.

· Import and Export data using R Programming

· Data Manipulation with R Programming.

· Joining/Merging ,Transpose with R programming.

· Knowledge in SAS functions, statements, formats & informats.

· Sound Knowledge in creation of datasets, Tables, Listings, Reports, and Summaries according to requirements in compliance to Standard Operating Procedures (SOPs), Statistical Analysis Plan (SAP) using SAS and R programming.

· Performed Data Validation and Data Cleaning on Clinical Trial data using SAS and R programming.

· Knowledge of quality customized reports by using PROC TABULATE, REPORT and SUMMARY and also provided descriptive statistics using PROC MEANS, FREQ.

· Knowledge of Designed LOT (list of tables) and Table Shells for the CSR submission of the study using SAS and R programming.

· Knowledge of Produced output in various formatted files such as Excel sheets, PDF and RTF using SAS/ODS.

· Write and review Statistical programs to create the manual and SAS checks of Clinical study (SAS programmer.

Knowledge of Developed and Analyzed Safety and Efficacy tables, Listings and Graphs and the Value added datasets according to standards.

· Knowledge of CRF-Annotation.

· Sound Knowledge of Clinical Data Management

· Well versed in Study Set-up, Study Conduct and Close-out phase.

• Review CRF/eCRF data for completeness, accuracy, and consistency via computerized edits and manual data checks
• Perform external data reconciliation
• Perform Serious Adverse Event reconciliation
• Generate and close/resolve (as appropriate) data queries
• Freeze and/or lock eCRFs (as appropriate) within the Electronic Data capture System
• Perform User Acceptance Testing and collaboratively work with CDMS personnel to see issues found through re-testing and resolution
• Identify and resolve data discrepancies in clinical data via computerized and manual data checks
• Be compliant with Standard Operating Procedure, work procedures and project scope of the work and ensure quality
• Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations
• Maintain documentation of training as appropriate
• As required, communicate effectively with the project team, study lead, Project lead and Project manager

• Create, maintain and update study specific documents like Data Management Plan, Creation of Data Validation Plan, database design specifications, external data handling plan and other study specific documents
• Co-ordinate with other study team members for data management related tasks on study activity
• Perform UAT in study database based on the edit checks created
• Check consistency of Data Entry screens with case report form
• Train the clinical sites on using the study specific database for Electronic Data Capture (EDC) studies
• Identify and resolve data discrepancies in clinical data via computerized and manual data checks
• Perform data management QC for assigned study
• Handle the external data and perform the applicable external data reconciliation process and resolve queries pertaining to the external data
• Perform Serious Adverse Event (SAE) Reconciliation and resolve queries pertaining to the SAEs
• Perform Medical Coding of terms reported on Case Report Form
• Be compliant with Standard Operating Procedure, work procedures and project scope of the work and ensure quality
• Maintain documentation of training as appropriate
• Work with other members of the project team
• This includes but is not limited to External team, Programmer, Statistician, Monitor and CRA
• Confirms to training schedule for self, maintains awareness of SOP content in the Data Management team, according to company requirements

• Follow Data Management Plan requirement throughout the project
• Preparation and review of documents generated during life of project
• E.g
• Case Report Form (CRF), CRF Completion guideline, Data Validation Plan (DVP), Edit check document, Project specific self-evident correction etc
• Database designing and testing
• Edit checks implementation, testing and documentation
• Data validation includes DCF generation and resolution, manual review of clinical data to check the discrepancy (ies)
• Correction of clinical data as per investigator's suggestion or Self-evident correction
• Preparation and review of other document related to CDM process and projects
• Check study specific CDM binder for completeness and correctness of required documents
• Maintenance of study binder in eTMF
• Coordination within and across the department for project related activity
• Medication coding by WHODD
• Follow the CDM SOPs, other departmental SOPs and applicable regulatory guidelines
• ECRF preparation and finalization for EDC module
• Conforms to training schedule for self, maintains awareness of SOP content in the Data Management team, according to company requirements

• Screened patient records, databases and physician referrals to identify prospective candidates for research studies
• Collected data and followed research protocols, operations manuals and case report form requirements
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
• Maintained compliance with protocols covering patient care and clinical trial operations
• Collected, evaluated and modeled collected data
• Gathered, processed and shipped lab specimens
• Followed informed consent processes and maintained records
• Clinical Research Therapeutic Areas include: Oncology: Triple-negative breast cancer, Multi-organ cancer; Rheumatology: Rheumatoid arthritis; Dermatology: Plaque Psoriasis, Skin infection; Psychiatry: Schizophrenia, Bipolar disorder; Endocrine/Metabolic: Diabetic Neuropathy; Cardiology: Post Myocardial Infarction Heart Failure