Job Profile

Job Title: Study Database Programmer

Position Location: Gurgaon

Department: Biostatistics and Data Management (BDM),

Scope: (describe the strategic and functional aspects of the job i.e managerial responsibilities,
category alignments, functions and or departments supported)

Provides database programming support and advice and local Infrastructure support tasks and
basic training and mentoring of new starters.

Reports to local India Data Manager / Team Leader.

Works across international and functional boundaries as needed within a project team
environment.

Works closely with Clinical, Medical, Statistics and Data Management team members.

Core Competencies Required: (Summarise the most important operational competencies

required to perform job.)

         Review, annotate, and approve CRFs

         Design, test and maintain data entry screens.

         Design, test and maintain databases

         Program discrepancy checks using PL/SQL code

         Test and maintain discrepancy/edit checks

         Setup electronic tracking system

         Setup Medical coding and Code Adverse Events (MedDRA) and Medications

         Importing and exporting data files

         Assist with creating, testing, validating database systems

         Assist with development of departmental guidelines in line with database set-up and
standards
          Basic technical training of new starters e.g. Basic Clintrial Training, Some WI and
SOP’s where appropriate.

         Generate and maintain study documentation

         Attend and participate in project team meetings

         Working knowledge of Documentum

         Awareness of MyLearning training system

         Working knowledge of applicable SOPs and Work Instructions

Qualifications: 

 Bachelor’s degree in Life Sciences, Mathematics, Statistics, Computer Science or a

Medical/Nursing qualification. 
 1 to 2 years of Oracle PL/SQL programming skills.
 Understanding of clinical trial methodology and GCP. 
 Experience and understanding of at least one clinical data management system (e.g.
Clintrial, Oracle Clinical). 
 Basic understanding of Software Development Lifecycle.
 Good verbal and written communication skills. 
 Ability to work on multiple projects, plan, organize and prioritize activities. 

Skills / Requirements beyond Basic:

 Knowledge of Framemaker, Inform and/or EDC systems an additional plus.