Quanticate UK - Head Office

Principal Clinical Data Management Programmer

IN-KA-Bangalore
5 months ago
ID
2017-1645
# of Openings
1
Category
Data Management

Overview

  • To administer, maintain and document the Oracle Clinical Instance
  • To manage the Oracle Clinical Global Library
  • To provide advice and training on the use of Oracle Clinical
  • To design, program and test study databases.
  • To provide technical support for systems deployed in CDM

Responsibilities

  • Administer, Maintain and Document Oracle Clinical
  • To document all processes related to the administration, security, access and use of Oracle Clinical
  • To ensure all documented procedures are adhered too
  • Support the Oracle Clinical maintenance upgrades and update patches
  • Conduct and document systems validation in accordance to industry regulations
  • To manage the Oracle Clinical Global Library
  • Provide global library services to the Data Management department
  • Document, maintain and uphold data standards
  • Drive database development efficiency through the standardisation of GLIB objects, DCMs, DCIs and validation procedures
  • To provide advice and training on the use of Oracle Clinical
  • Provide structured training sessions to teach Oracle Clinical database development, validation procedure writing, testing, data entry and discrepancy management
  • Mentor CDM Programmers on database development best practices
  • Project management for allocated projects
  • To manage timelines and resource
  • To report progress against schedules to management
  • Set up of data management for allocated projects
  • To annotate the master CRF
  • To develop study databases and conduct formal testing
  • To program study database edit checks and conduct formal testing
  • To assist/prepare in the creation of all data management documentation as appropriate
  • Management of study files for allocated projects
  • To maintain study master file and to ensure that the correct documents are within the file when they become available for all allocated projects involving data management.
  • To produce a clear breakdown of bookable time for invoicing.
  • To be aware of and to work to the standards appropriate to the study.
  • To advise on possible improvements to procedures and standards.
  • To perform other reasonable tasks as requested by management.

Qualifications

  • Qualified to minimally BSc, BA or equivalent, preferably in a numerate discipline
  • Having relevant past experience within the pharmaceutical Industry.
  • A minimum of 5 years experience in a technical role within Clinical Data Management in the pharmaceutical industry.
  • PC Skills , including good knowledge of programmer software languages such as SAS / PL/Sql.
  • Knowledge of industry standard systems (Oracle Clinical, Clintrial etc )
  • Knowledge of EDC systems
  • Excellent people management skills
  • Good organisational skills
  • Good communication skills (oral and written), good analytical skills.

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