Satyender Kumar Arya

Biography

  Experience CLINICAL DATA MANAGEMENT Company NamePanacea Biotec Ltd Dates EmployedFeb 2009 – Present   Employment Duration8 yrs 8 mos LocationNew Delhi Area, India •Train and Mentor, new recruits on ‘Oracle Clinical’ and company specific Standard Operating Procedures •Handling many clinical trials as a project in-charge •Prepare, review and finalize CDM Standard Operating Procedures/WIs •SOP: Workflow in Clinical Data Management CRF & RDC Study.  •SOP: Data Extraction of a Clinical Study from Oracle Clinical to SAS •SOP: Right of access (role) in Paper •Interface with clinical operation team for various clinical CDM related activities •Prepare and maintain ‘Master Data Management File’ (MDMF) study related documents. •To prepare/review ‘Technical Operating Manuals’ (TOMs) for using Oracle Clinical. •e-CRF designing and programming in Oracle Clinical for RDC of clinical trials •Prepare CRF, Protocol Alignment document (CAPA), study specific Data Management Plan (DMP) •Preparation of collation list and subsequent Database Designing •Preparation of edit specifications document and based on the final document, programming for validation procedures in the database Education Institute of Clinical Research (India) Degree NameCertification Course Field Of StudyOracle Clinical GradeA Dates attended or expected graduation2010 – 2010 Activities and Societies: ïƒ˜Training in CDISC (Clinical Data Interchange Consortium) Standards Kinship, Bangalore, Panacea Biotec Ltd. Remote data Capture (RDC) Training in Panacea Biotec Ltd., New Delhi (HCL) SDTM Implementation Training Program: Workshop, 11th December, New Delh.Trainer: Dr. Mandar Oak and Dr. Sheljha SDTM and CDASH Implementation training program: workshop in 09-12 Nov2011,New Delhi (Panacea Biotec Ltd) Trainer: Dr. Mandar Oak

Research Interest

 Seasoned Clinical Data Management professional with experience as the Data Management Project Lead responsible for overseeing database design, data management plans, edit check and data listings specifications, edit check testing, Batch Data Load, external data transfer plans and specifications, data status reports, and other documentation and procedures required for preparing and completing databases from study start-up to study lock. Proven ability to lead and mentor the team to ensure proper study maintenance and progression. Pro-active approach to help meet the timelines while ensuring the quality