Job Description

Site Name: Bengaluru Luxor North Tower
Posted Date: Aug 24 2022
Is there any greater challenge than getting ahead of disease? We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated. In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention. Job Purpose:- The role is primarily responsible for the technical development of electronic Data capture (eDC) and/or Electronic PatientReported 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 responsibilites 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).

Knowledge/Education Required:- Minimum Level of Education Required - Bachelors or equivalent Area of Specialization - Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent Previous Experience Required:- Minimum Level of Job-Related Experience Required - 4+ years of data acquisition experience or related job experience in Clinical Research or Information Systems and/or relevant scientific experience Job-Related Experience sections above that are required for the job:-
Soft skills

• Excellent communication skills within a matrix environment
• Good analytical, problem solving and project delivery skills
• Fluent English (written and spoken)
• Team spirit – ability to facilitate interfaces within extended network
• Good time management skills: ability to manage time and priorities
• Ability to anticipate for changes and be flexible in their implementation
• Problem solving mindset
• Quick learner
• Ability to handle technical and complex topics
• Proactive, flexible and stress resistant
• Results oriented and customer focused
• Willing to work in an international environment
• Innovative/Flexible thinking, process minded, keeping openness for specific project needs

Hard skills

• 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

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 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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