EDC, eCRF Programmer
- Pinehouse, SK
Site Name: Canada - Ontario - Mississauga, Home Worker - GBR, UK - London - Brentford, UK - Middlesex - Stockley Park, Home Worker - USA
Posted Date: Jun 19 2020
GlaxoSmithKline is one of the world's leading pharmaceutical and healthcare companies. We are looking for an enthusiastic and innovative individual to join our global team within the Clinical Data Acquisition and Delivery group for Electronic Case Report Forms (eCRF) Development and setup of Clinical Trials. The successful candidate will work closely with key study team members to drive and deliver the eCRF and technical strategies for clinical studies.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Provide technical and feasibility input into protocol development by working closely with stakeholders in Data Management, Clinical, and Statistics and Programming for eCRF and Data Extraction
- Work closely with the Data Standards organization in creating new standards to deliver CDISC compliant data
- Lead study teams for eCRF development based on current standards/library and protocol requirements
- Manage and deliver eCRFs based on the agreed specifications
- Setup and lead multiple integrations for various systems and tools (safety, coding, site payments, SDV for RBM, etc.)
- Define and program edit checks
- Serve as technical expert for project teams and support multiple tools used for eCRF development
- Strong adherence to best practices, process, SOPs, and Guidelines
- Ensure data programming procedures are of the highest quality and are audit ready
- Subject Matter Expert for the Data Management Community bringing programming expertise, which includes expert input into the development, implementation, and communication of programming processes and control documents
- Oversee off shore partners/vendors to ensure delivery per the provided requirements and specifications
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree
- Experience leading cross functional teams to create eCRF specifications and manage programming/development of the eCRF against the agreed specification
- Programming and technical capability experience in one or multiple languages such as PL/SQL, SAS
- Experience in creating specifications, managing timelines, delivering to timelines and working in regulatory environment
- Experience learning new process, programming languages and new technologies
- Eligibility to work in the country is required. Sponsorship not available.
If you have the following characteristics, it would be a plus:
- Data extraction and CDISC experience
- eCRF database development experience (ex: Central designer, RAVE, Veeva)
- Have complete e2e technical and strategic understanding of products relevant to clinical data management
- Knowledgeable in regulatory requirements for electronic submissions
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 expectationsare 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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