Locality: Warangal Area, India
Summary: *Working in the domain of Clincal Data Management from 2 yrs. * Overall knowledge of complete process flow in Clinical Data Management. * Worked with Clinical Tools like InForm, Clintrial and Oracle Clinical. * Good Comprehension of FDA and CDISC guidelines, Good Clinical Practice (GCP), International Conference of Harmonization (ICH) and other regulatory guidelines (NDA). * Knowledge of 21 CFR Part 11, Good Clinical Data Management Practice (GCDMP) and CDISC standards. * Excellent managerial skills with ability to handle a team of expertise in clinical research. * Overall knowledge of Clinical Data Entry process, Data Validation like Discrepancy Management, SAE Reconciliation, Coding etc including Quality control. * Highly committed towards assigned work. * Ability to work independently and manage time appropriately * Good negotiation and decision-making skills Very much interested to explore things in DataManagement. Hard working, Passion in DM
Current: Clinical Data Analyst at MakroCare Clinical Research Limited
Past: Sr. Process Executive at Cognizant Technology Solutions
Education: Kakatiya University Life Sciences (2005-2008)
BIE, Andhra Pradesh
Ekashila High School, Jangaon
Skills: 1.Query management in cllinical data management 2.Study set up activities 3.User acceptance testing of the database, tools and applications
Experience: MakroCare Clinical Research Limited (Privately Held; Pharmaceuticals industry): Clinical Data Analyst, (July 2010-Present) -Handling all Clinical Data Management activities.
Cognizant Technology Solutions (Public Company; CTSH; Outsourcing/Offshoring industry): Sr. Process Executive, (November 2008-July 2010) -Performing DM activities using Clinical T...
Interests: Listening to Music, Dance.
Interests: career opportunities, consulting offers, new ventures, job inquiries, expertise requests, business deals, reference requests, getting back in touch
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