Basic Qualifications:
1. Minimum 5 yrs experience.
2. Experience in managing external data ( eCOA, biomarker, lab, etc.)
3. Understanding of SDTM CDISC concepts for external data.
4. Data Transfer agreement setup, import and ingestion concepts, vendor stakeholder management.
5. Strong communication to work in team.
Key Responsibilities:
• Performs the study set-up activities and the technical development of Electronic Data capture (eDC) solutions and associated tools for one or more clinical studies.
• Assist with the technical & vendor oversight of multiple data types for one or more clinical studies
• Support the delivery of one or more Clinical studies depending upon the phase, complexity, and similarity with support of junior data acquisitions staffs as required.
• For studies, key responsibilities include:
o Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate.
o Coordinates review, revision, and approval of study specification documents (including operational requirements & specifications) and/or key vendor deliverables (including translations)
o Understands, mediates and solves issues related to Data acquisition Develops the study eDC application and associated documents including forms, data validation checks & data extraction and ensures delivery with quality and on time
o Provides reports, status updates, feedback, and raises risks and advice to Study Data Manager about study set-up and/or vendor related activities
o Ensures quality control of deliverables.
• Provide inputs to process improvements, new processes, training, quality assessments, audits and inspections related to the Data Acquisition.
• Responsible for performing after-action reviews (success or failure) to share learnings and propose improvements for the future.
• Extensive working knowledge of GxP, ICH requirements, internal processes and external regulations that govern drug development (where applicable).
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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