Study designer

Amarnath Reddy

Mobile: +91-979******* E-Mail: ********.*****@*****.***

#*/***, *** *****, *** Cross Street, Periyar Nagar, Senneerkuppam, Avadi Road,

Poonamallee, Chennai - 600056

In quest of challenging assignments in the field of Clinical Data Management to provide professional growth to the success of the organization

Professional Profile

• More than 30 months of experience in Clinical Data Management

• Deep knowledge of clinical trials process, the industry and electronic data capture.

• Well versed with ICH-GCP and FDA guidelines. Work profile as per CFR-21 Part 11.

• Experience in EDC tool Rave and client specific tools such as AMOS, iPRO, SPOLA.

• ASPire to Win certified study developer in Medidata Rave 5.6.3

• Study setup including specification creation for eCRFs, Validations, Reports, data extracts, Lab data integration, Third party data integration etc.

• Experience of working with multiple clients in Clinical Data Management for setting up studies, which provided enormous knowledge of client requirements.

• Managing team as per the priorities, providing valuable suggestions and mentoring new hires.

• Handling study Matrix and participating in the study initiation meetings.

• Experience of study setup in Japanese and understanding requirements

• Oncology study design experience with setup of libraries including RECIST 1.1 standards

• Meeting management performance standards, team supervision and performance management activities

Career Profile

Total Experience – 2 years, 8 months (Nov-2006 to Present date)

Cognizant Technology Solutions, Chennai, India: Jan-2008 to Present date

Role: Study Setup Specialist

Accenture Services Pvt. Ltd, Bangalore, India: Nov 2006 to Jan 2008

Role: eCRF Designer and QC Tester

Career Highlights

Cognizant Technology Solutions, Chennai

Domain Expertise

• Trained the new hires with the process and team activities

• New recommendations to improve the process and teams performance.

• Participate in study timeline and study deliverable meetings to priorities the study activities.

• Giving valuable suggestions to the management about the data flow in Rave system.

• Integrating the IVRS & IWRS data into the Rave system using Rave Batch Up loader.

• Knowledge Transfer for the studies involving Local/Central Labs and integrating the Lab data with Rave system.

• Standardized the system and documented process to conduct the early phase studies in Rave.

• Maintaining the Rave Global Libraries to meet the study requirements including RECIST setup in Rave libraries

• Study setup support from On-site (Japan), for setting up study in Japanese

• Understanding Study protocol and paper CRF in Japanese

Significant Achievements:

• Worked with IS-IT team to standardize the process for study setup and data flow in/out of Rave system.

• Took over the leadership of maintaining the Rave Global Libraries required for study setup in Rave system.

• Appreciated by the Manager and the DM team Leads for the presentation on Maintaining and upgrading the Rave Global Libraries.

• With providing various innovative ideas for the team, the manager has suggested the name to work with the innovation process team.

• Visited Japan to support study in Japanese language and got many accomplishments for completing study in 45 days.

Accenture Services Pvt. Ltd, Bangalore

Domain Expertise

• Developing electronic case report forms for Clinical Data Capture and Management using Medidata Rave Tool.

• Write validations, Configure validations, Verify the validations implemented in the EDC study and setup of eCDM systems and peer review as required.

• Execute Quality Control and Quality Assurance test scripts on eCDM systems.

• Performs testing on RAVE-EDC Core Configuration, Standard Edit Checks, Outputs, Reports and Study Close.

• Record and track defects uncovered during the execution of development.

• Train new hires to configure and build systems using Medidata RAVE tool.

• Communicate issues to QC management for escalation and participate in meetings to address research options.

Significant Achievements:

• Awarded as the best performer of the Quarter, June-2007 and Promoted as the QC Tester for eCRF designs in recognition of the outstanding performance.

• Awarded as the Life Savior (Award given for best team supporter) for the month of August 2008.

IT Skills

• Well conversant with Windows 2000 & XP2000, MS- Office.

• Knowledge of Bioinformatics and Biostatistics.

• Knowledge of C Program.

Academia

• MSc (Microbiology) from Al-Ameen College, Bangalore University, Bangalore [2004 – 2006]

• BSc (Biotechnology) from Govt Science College, Bangalore University, Bangalore [2001 – 2004]

Personal Details

Father : Ramoji Reddy

Mother : Saraswathamma

Permanent address : #1/7 Devaganapally, Gopanapally Post,

Hosur Taluk, Tamil Nadu, India-635110

Ph: 043**-******

Date of Birth : 8th June 1984

Marital status : Unmarried

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