GlaxoSmithKline Data Acquisition Analyst - EDC/eCRF Programmer in United States
Data Acquisition Analyst - EDC/eCRF Programmer
Open date:Apr 19, 2018 3:04 PM
Functional area:Science and Technology
Experience required:Not Indicated
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Your Responsibilities:Do you want to be a part of a pioneering industry change working on the latest tools with one of the most trusted companies in the Clinical Development space?
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.
You will be 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 check along with programming and validation.
You will work closely with the 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.
· 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.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Closing date for applications: 3rd May 2018
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you for your interest in this opportunity.
Basic qualifications:• Bachelor's Degree or higher in mathematics, statistics, computer science or related discipline.
• eCRF programmer with experience in creating eCRFs using any of the eDC tools (ex: Central designer, RAVE)
• 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
• 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
Why GSK?:At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires
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