Clinical Database Programmer II

1 month ago

Chandigarh, Chandigarh, India Parexel Full time

Job Summary

The Clinical Database Programmer II provides technical expertise for the conduct of clinical trials, working with minimal supervision to support various programming activities related to clinical systems and eClinical technologies.

Key Responsibilities

  • Create and implement database set-up for paper-based and web-based clinical data management systems (CDMS) in standard format or CDISC compliant format.
  • Develop and maintain consistency checks for database builds in CDMS and EDC, following internal and external regulatory requirements.
  • Accountable for first-time quality on all deliverables.
  • Provide feedback to study programmers on the creation of eCRFs following SOPs and internal process guidelines.
  • Assist in providing technical solutions to internal or external client inquiries.
  • Develop knowledge of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), and other programming language usage and processes within the GDO area.
  • Ensure adherence to service levels agreements regarding turnaround time from the point when specifications are finalized.

Requirements

  • Good English written and oral communication skills.
  • Demonstrate ability to learn new systems and function in an evolving technical environment.
  • Attention to detail.
  • Ability to work together with a team (including international teams as required) as well as independently.
  • Work effectively in a quality-focused environment.
  • Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
  • Business/Operational skills that include customer focus, commitment to quality management, and problem-solving.

Preferred Qualifications

  • Experience in at least one programming environment (e.g. SAS, CDMS, EDC, SQL, VB, Java).
  • Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies, ICH-GCP, and any other applicable local and international regulations.

Education

  • Bachelor's degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience.

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