Lead Analyst, Study Data
Company Name:-
GSK
Job Location:-
Bengaluru, Karnataka
Job Summary:-
Site Name: Bengaluru Luxor North TowerPosted Date: May 6 2021
Are you looking for an opportunity to support process improvement initiatives and shares best practices related to Clinical studies and projects? If so, this is the role for you.
Analyst Study Data is responsible for data cleaning activities on a day to day basis for the assigned clinical studies by adhering to related GSK standard operation, guidance and procedural documents by ensuring quality and delivery according to the set timelines.
This role will provide YOU the opportunity to lead key activities to progress
Assist with the development of Data Management Plan, clinical data model and/or database design, annotated CRF, Quality Management Plans, data review guidelines, CRF (eCRF) completion guidelines and any Data Management relevant guidelines/documents for the study that will delivery accurate, timely consistent and quality clinical data.
Write and executes the validation plan of checks/specific listings, performs UAT of eCRF screen when needed for an assigned study(s) as per the relevant SOP.
Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug Safety, etc.
) to support the set-up, maintenance and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
Perform and Oversee all Data Cleaning activities and Provide relevant data cleaning reports, status updates, feedback on trends throughout the study course.
Provide inputs for development and enhancement of standard data checks and listing.
Complete required trainings according to timelines and Adhere to the relevant departmental SOPs, regulatory requirements and industry best practices.
Trains and mentorsÂ’ peers by providing timely feedback to trainee and management as appropriate.
Develops recommendations for study or project issue resolution and serves as a platform or process-specific Subject Matter Expert (SME) in supporting Business Excellence in the implementation of new processes, trainings, systems, vendor quality assessments, audits and inspections.
Drives and supports process improvement initiatives.
Support Manager-Study Data as back up when requi
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