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Work experience

Nov 2011Present

CLINICAL DATA ANALYST TRAINEE

CLINEXA LIFE SCIENCES
  • Performing Production data entry – Initial Login, First and second pass data entry
  • Raising manual queries to the site.
  • Discrepancy Management – Generating, Reviewing and updating Discrepancies using the Oracle Clinical Discrepancy database
  • DCF Management– Generating, Reviewing, Printing and updating Data Clarification Forms
Feb 2010Oct 2011

JUNIOR RESEARCH ASSOCIATE

GVK BIO SCIENCES

Organisation - Informatics division, GVK Biosciences Pvt. Ltd Hyderabad

Designation - Junior Research Associate

Team size-30 researchers

Carrier level- Middle management

The Profile:

Key Responsibilities:

  • Data capturing from web-based sources
  • Clinical data entry & management in an oracle based in-house tool
  •  Query generation & discrepancy management
  • Performing data management activities on the assigned project in a timely and efficient manner
  • Data cleaning & validation activities
  • Working under strict regulatory environment & Data management plan
  • Creating edit/checks for oracle based tool
Jul 2008Oct 2009

Clinical Research Co-ordinator

SABOO HOSPITAL AND RESEARCH CENTRE

Organisation – Saboo hospital and Research Centre - Hyderabad

Designation – Clinical Research Co-ordinator

Key Responsibilities:

·e-CRF, paper CRF maintenance and entry

·Resolution of study related queries

·In-house monitoring of documents for best result during trial

·Ethics committee file maintenance for correspondence documents

·Patient data maintenance according to ICH GCP and schedule Y

·Communication with study monitors (CRA) and other project members

·Performing IVRS/IWRS activities during clinical trial

·Preparation of site for monitoring visit

·Maintenance of IP dispensing and accountability

Education

Jul 2005Oct 2007

M.Sc

H.N.B Garhwal University
20022005

B.Sc.

M.J.P RohilKhand University

Skills

Oracle Clinical
  Enterprise Applications in Clinical Data Management Hands on Experience with Oracle Clinical Planning a clinical study Designing a clinical study by creating Intervals, Clinical Planned Events, Patient Positions and Treatment Patterns Global Library Management Creating DVGs, Questions, Question groups, DCMs and DCIs as a part of designing Data Entry screens using Case Report Forms (CRFs) in Oracle Clinical Generating and Testing Data Entry screens Data Validation – Validation Programming, Generation, Execution and testing output. Production Data Entry – Initial Login, First and Second pass data entry, Browse, Update and Key changes Discrepancy Management – Generating, Reviewing and updating Discrepancies using the Oracle Clinical Discrepancy database DCF Management– Generating, Reviewing, Printing and updating Data Clarification Forms ICH-GCP guidelines, schedule Y & Indian GCP Drug safety & efficacy, 21 CFR part 11 MedDRA, ICD-10 & Safety profiler eCRF, data management & documentations Familiar with different Electronic Data Capture, Medidata-Rave, Oracle clinical, Inform etc.  

References

Abdul Wahid

Objective

Want to be an efficient team member and contribute to a project from scratch with the compliance of International standard & regulatory guidelines to apply my skills and achieve targets in an innovative and challenging environment of clinical data management to advance in my career & that will help augment my skills in this arena

Certifications

Nov 2011Jun 2012

PG Diploma in Clinical Research and Data Management

James Lind Institute in Collaboration with Global Hospitals