Naim Ahmad

Work History

Work History
Nov 2011 - Present

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 2010 - Oct 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 2008 - Oct 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

Education
Jul 2005 - Oct 2007

M.Sc

H.N.B Garhwal University
2002 - 2005

B.Sc.

M.J.P RohilKhand University

Skills

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.  

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

Certifications
Nov 2011 - Jun 2012

PG Diploma in Clinical Research and Data Management

James Lind Institute in Collaboration with Global Hospitals