Satyender Kumar Arya
Clinical Research Network India
- Role
- Clinical Data Management at Panacea Biotec
- Location
- South Delhi, DL, IN
- LinkedIn followers
- 500 followers
About Satyender Kumar Arya
Seasoned Clinical Data Management professional with experience as the Data Management…
Experience
Clinical Data Management
Feb 2009 — Present · New Delhi, IN
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)
Certification Course
2010 — 2010
S.D COLLEGE MUZAFFAFAR NAGAR UP
Bachelor's degree
1994 — 1998
Skills
- Ich-Gcp
- Clinical Development
- Laboratory Data
- Clinical Data Management
- Oracle Clinical
- Regulatory Affairs
- Corrective and Preventive Action (Capa)
- Data Management
- Clinical Database Designing
- CRO
- Pharmaceutical Industry
- Sop
- Cdm Swim Lane Diagram
- Discrepancy Management
- Standard Operating Procedure (Sop)
- Management
- Data Management Plan
- Documentation
- Data Mapping
- Medical Coding
- Sdtm
- Database Design
- Gcp
- Clinical Trials
- Databases
- Clinical Research
- Sas
- Remote Data Capture
- 21 Cfr Part 11
- Good Clinical Practice (Gcp)
- Oracle Clinical Version 4.5.3
- Oncology
- Protocol
- Oracle Rdc
- Cdisc
- Validation
- Chash
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