Job Location: Bengaluru
Posted Date: Oct 11 2022
Ready to help shape the future of healthcare?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
Job Purpose
The role is primarily responsible for the technical development of electronic Data capture (eDC) and/or Electronic Patient-Reported Outcomes (ePRO) solutions and/or the technical acquisition of vendor data to support the delivery of data acquisition and related processes for one or more studies. This role may act as a Subject Matter expert for one or more data acquisition applications/processes.
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 study(ies).
- Assist with the technical & vendor oversight of multiple data types for one or more clinical study(ies)
- 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:
- Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate.
- Coordinates review, revision, and approval of study specification documents (including operational requirements & specifications) and/or key vendor deliverables (including translations)
- 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
- Provides reports, status updates, feedback, and raises risks and advice to Study Data Manager about study set-up and/or vendor related activities
- 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).
Knowledge/Education Required
- Bachelor’s degree in Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent
- 4+ years of data acquisition experience or related job experience in Clinical Research or Information Systems and/or relevant scientific experience
- Experienced in Data Management in the pharmaceutical industry
- CDISC Knowledge
- Knowledge of multiple programming languages (PL/SQL, SAS, Python, C#, etc.)
- Experience working in database systems and environments, including Oracle and Unix
- Understanding of general data flow & database architecture concepts
- Good understanding of regulations including ICH-GCP
- Experience developing programmatic transformations of clinical laboratory data
- Knowledge of medical terminology related to biospecimen collection and assessment
- Experienced in eDC solutions (Inform, Rave, Veeva CDMS Vault) and ePro solutions
- Knowledge required to ensure the end-to-end eDC study setup and/or technical & vendor data acquisition of multiple data types (Central Labs, RNA/DNA sequencing, Flow Cytometry, Complex Biomarkers, eCOA, Microscopy, Immunohistochemistry, Ocular assessments, Imaging, etc) on a day-to-day basis and accountability of the related deliverables in terms of quality & delivery to plan.
At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
- LI-GSK
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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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