Satish M.

Objective Intuitive, Creative, Analytical Over-thinker: seeking a position as an organizational, management, or Clinical Data Analyst. Qualifications: - Bachular Degree in Science and Professional Diploma in Clinical Data Management. - Four years experience in Clinical Data management, Clinical data project handling and team handling. - Outstanding communication skills, both verbal and written, and an inane ability to think strategically and problem-solve effectively. Technical Skills: - Various Clinical Data management databases: EDC systems: InForm, Rave and Data Labs. Paper Systems: Oracle Clinical and Data Fax - Microsoft Office, Including Excel, Word, PowerPoint, and Outlook. Experience: Clinical Data Analyst - II aug 2008 – present. PAREXEL INTERNATIONAL - Project team leadership experience - EDC and Paper based Study experience - Hands on experience with tools: EDC tools: INFORM, Rave and Data Labs Paper based tools: Oracle Clinical (OC) and Data Fax - Drive the activities like eCRFs freezing and eCRFs locking to achieve the final database Lock. - Discrepancy Management experience - Query Management experience - Ability to work independently, under pressure demonstrating initiative and flexibility - Data base User acceptance test experience - Edit checks User acceptance test experience - Serious Adverse Event Reconciliation experience - ECG Reconciliation and Lab Reconciliation experience - Creating Study documents like CCI experience - DVS Writing experience, - Writing UAT test data experience - Knowledge in data base structures (forms, visits, variables) - Knowledge in data review and can request listings needed to perform data review - Assumes overall responsibility for the successful execution of the projects assigned to me. - Maintains study documentation training records and other important documents with wet ink signature as well as soft copy documents of the projects assigned to me. - Perform formal quality check of team members to ensure data base quality. - Strong organizational and attention to detail skills. - Thorough knowledge of applicable regulatory rules and guidelines; e.g. ICH, GCP. - Good interpersonal and communication skills and ability to operate effectively in an international environment. - Help create, modify, and publish operational querying reports pursuant to internal and sponsor reporting needs. - Ability to Identify, troubleshoot, and resolve simple-to-complex data related concerns and provides a thorough explanation of the issue and the intended action plan to resolve such matters. Clinical Data Analyst – I Sep 2007 – Aug 2008. ICON CLINICAL RESEARCH - Lead a small project team. - Paper based Study experience - Hands on experience with Paper based tools: Oracle Clinical (OC) and Data Fax - DB lock experience - Discrepancy Management experience - Query Management experience - Ability to work independently, under pressure demonstrating initiative and flexibility - ECG Reconciliation and Lab Reconciliation experience - Knowledge in data base structures (forms, visits, variables) - Assumes overall responsibility for the successful execution of the projects assigned to me. - Maintains study documentation training records and other important documents with wet ink signature as well as soft copy documents of the projects assigned to me. - Strong organizational and attention to detail skills - Thorough knowledge of applicable regulatory rules and guidelines; e.g. ICH, GCP - Good interpersonal and communication skills and ability to operate effectively in an international environment - Ability to Identify, troubleshoot, and resolve simple-to-complex data related concerns and provides a thorough explanation of the issue and the intended action plan to resolve such matters. CLINICAL DATA COORDINATOR Nov 2005 - Sep 2007. Dr. Reddy’s Laboratories Ltd. - Worked as a team member and performed complete data management activities from setup to DB lock and QC after programming. - Paper based studies on customized database. - DB lock experience - Discrepancy Management experience. - ECG Reconciliation and Lab Reconciliation experience. - Good interpersonal and communication skills. - Test data writing experience, - User Acceptance Test of customized database, - Lead Data entry team and responsible for completion of data entry with standard quality, addressing issues in Data compare. - Database lock experience. - QC of listings, Tables and Figures after Biostatics programming. - Trail Master File maintenance Education: - Bachelor Degree in Science (Chemistry, Physics, Geology) From Andhra University Vishakhapatnam, April, 1998. - Professional Diploma in Clinical Data Management From Catalyst Clinical Services, Delhi. May, 2008. - PG Diploma in Computer Applications From Andhra University Vishakhapatnam Apr 1997.