EDC / eCRF Programmer

GSK - Mississauga, ON (5 months ago)

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Site Name: Canada - Ontario - Mississauga
Posted Date: May 1 2020

** Please note – there are 2 vacancies available. See below for details **

GlaxoSmithKline is one of the world's leading pharmaceutical and healthcare companies. An opportunity has arisen in within the Clinical Data Acquisition and Delivery group to support the Data Acquisition domain. We are looking for an enthusiastic and innovative individual to join our team, who will provide lead and deliver eCRFs and drive the technical strategies for clinical studies.

Tasks will include: creating eCRF technical specification, lead study teams in approving the eCRF specification, oversee vendor in the development of the agreed specification into eCRF, create forms, edit checks along with programming and validating them. Work closely with Data Standards organization in creating new standards to deliver the data in CDISC and with key stakeholders in Data Management, Clinical and Statistics and Programming to meet the clinical trial requirements. Lead and support customers with their programming and technical needs for various systems used by the Data Acquisition team.

Key Responsibilities:
Contribute to the technical strategy and delivery for global clinical projects. Includes working with representatives from multiple project teams, including data management, clinical data standards and statistics and programming
Provide technical input to protocol and other plans at the development phase of a study
Coach and mentor colleagues and customers with programming tasks
Provide input to the development of data capture tools for a clinical study
Strong adherence to best practices, process, SOPs and Guidelines
Ensures data programming procedure are of the highest quality and are audit ready
Subject Matter Expert for the Data Quality Community bringing programming expertise, which would include expert input into the development, implementation and communication of programming control documents

Basic Qualifications:
Bachelor's Degree or higher in mathematics, statistics, computer science or related discipline.
eCRF programmer with at least 5 years of experience in creating eCRFs using any of the eDC tools (ex: Central designer, RAVE)
Has proven experience in creating eCRF specifications, managing timelines, leading study teams and overseeing vendors
Experience with data management tools, technologies and processes
Ability to learn new process, programming languages and adapt with new technologies

Preferred Qualifications:
Experience in programming in Central Designer or other ECRF development tools
Data extraction and CDISC experience
DMW (Data Management Workbench) experience
Lead study teams for eCRF trial development, specification, programming clinical protocol
Provide oversight of vendors to ensure they are delivering based on the requirements and specifications
Serve as technical expert for Therapeutic area and project support.
Expert in database programming and programming languages including PL/SQL, SAS
Assess database design requirements relevant to data capture tool, data extraction, processing and reporting.
Manage the Design specification, development, testing and validation of electronic case report forms, edit checks standards and dataset extraction.
Make recommendations to management concerning complex technical issues and provide solutions.
Have a complete e2e technical and strategic understanding of products relevant to clinical data management.
Be knowledgeable in regulatory requirements for electronic submissions.
Accountable for audit readiness for data acquisition process and documentation
Able to manage multiple studies and projects simultaneously and deliver on the timelines

Additional Qualifications:
  • These qualifications are with reference to the 2nd vacancy mentioned above, which requires a more broadly skilled programmer familiar with pharma research
At least two programming languages (preferably Python, SAS, C# or VBA)
Database structures and use of SQL, Oracle SQL
Experience in providing and presenting reports (e.g. system metrics)
Provide support for in-house applications, including system validation and end user training
Testing automation (e.g. HP ALM)
Pharma background, GCP, knowledge of clinical trial data acquisition processes and systems

  • LI-GSK
GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com

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