EDC, eCRF Programmer
Site Name: UK - Middlesex - Stockley Park, USA - Pennsylvania - Upper Providence
Posted Date: Feb 10 2020
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.
- 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
- 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
- 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
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.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
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