Senior Analyst, Study Data
Company Name:-
GSK
Job Location:-
Bengaluru, Karnataka
Job Summary:-
Site Name: Bengaluru Luxor North TowerPosted Date: May 11 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
Reviews the Data Management Plan and associated documents and follow relevant checks, listings, cleaning plan, data cleaning strategy etc.
Adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s) by reviewing & processing clinical trial data to ensure the accuracy & consistency of clinical databases.
Writing and posting data queries to sites for discrepant data, resolve answered queries and re-queries where appropriate.
Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data etc.
are consistent with data in the clinical database.
Use the specified reconciliation process to document and query any such discrepancies found with the appropriate party.
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.
Contributes to the process of database freeze and archival of documents in the eTMF relevant to the role
Provides relevant data cleaning reports, status updates, feedback on trends throughout the study course.
Complete required trainings according to timelines and Adhere to the relevant departmental SOPs, regulatory requirements and industry best practices.
Apply quality control procedures and checks to ensure data quality standards are achieved.
Trains and mentorsÂ’ peers by providing timely feedback to trainee and management as appropriate.
Ability to handle multiple tasks and perform other duties as assigned by Study or Line Manager
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals
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