QED Pharmaceutical Services
Quality and Ethics in Data

Actively recruiting for the following positions

Apply by sending an e-mail to Careers@qedpharma.com with your Resume.

Clinical Data Manager

The Clinical Data Manager is responsible for overseeing all data management activities pertaining to the conduct of Phase I-IV clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met.

Job Responsibilities
  • Participate

    • T As the primary data management representative on the QED multidisciplinary project teams.
    • As the primary point of contact for all data management interactions with the Sponsor.
    • In protocol developments and review
    • In review of clinical study reports and statistical analysis plan
    • In the development of data dictionaries complete with variables, value specifications and coding standards
    • In monitoring the quality of data management processes, data and performance
  • Review and provide

    • Inputs to CRF design and CRF Completion Instructions
    • Database design, data management/data validation plans and data entry guidelines
    • Revisions to the Standard Operating Procedures
  • Manage

    • Resource planning methodologies and project management
    • To ensure study deliverables and timelines are met in collaboration with the Sponsor
    • The Sponsor change order process
    • To ensure effective communication exchange between the multidisciplinary project teams
  • Assist/Work with Sr. Management

    • In identifying, developing and implementing processes to improve/enhance time and cost efficiencies
    • To provide current information and potential impact of changes on project deliverables and timelines
    • To identify trouble-shoot issues and provide proposed solutions for problem resolution
    • To evaluate future potential data management solutions (e.g functional service provider models, EDC systems) and prepare a business plan
    • To individual development, training, knowledge and expertise through research, technical bulletins and attending appropriate seminar
  • Endorse and convey QED's corporate mission statement

  • Bachelor's/Master's degree in a computer science, statistics, clinical research, biotechnology, from an appropriately accredited institution..
  • Minimum of 5 years of data management experience
  • Project management experience is required.
  • Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is required.
  • Direct management of employees within Clinical Data Management is preferred.