Life Science Analyst Study Data Job at GSK
Life Science Analyst Study Data Job at GSK. GlaxoSmithKline Analyst, Study Data job opportunities. Careers at GSK. GlaxoSmithKline GSK Bengaluru vacancies for Analyst, Study Data. Check out all of the details below:
Name of the Position: Analyst, Study Data
Locations: Bangalore, India
Categories: Medical and Clinical
Req ID: 289550
Are you looking for an opportunity to support process improvement initiatives and shares best practices associated with Clinical studies and also projects? If so, this is the role for you.
Analyst Study Data is accountable for data cleaning activities on a day to day basis for the assigned clinical studies by adhering to related GSK standard operation, guidance as well as procedural documents by ensuring quality as well as delivery according to the set timelines.
This role will certainly provide YOU the opportunity to lead key activities to advance YOUR career. These responsibilities consist of some of the following:
- Reviews the Data Management Plan and also associated documents and also 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 guarantee the accuracy & consistency of clinical databases.
- Writing as well as posting data queries to sites for discrepant data, resolve answered queries and also re-queries where appropriate.
- Analysing as well as resolving discrepancies identified by the programmatic checks within the eCRF system and during manual data review.
- Guarantees 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. Utilize the specified reconciliation process to document as well as query any type of such discrepancies found with the appropriate party.
- Adds to the process of database freeze and archival of documents in the eTMF relevant to the role
- Provides pertinent data cleaning reports, status updates, feedback on trends throughout the study course.
- Complete required training according to timelines as well as Adhere to the pertinent departmental SOPs, regulatory requirements as well as industry best practices.
- Apply quality control procedures and checks to guarantee data quality standards are achieved.
- Ability to handle multiple tasks as well as perform other duties as assigned by Study or Line Manager
We are looking for professionals with these required abilities to achieve our goals:
- Master’s degree in Life Science Graduate Degree
- Understanding the clinical environment, complex processes and also systems in the pharmaceutical industry.
- Minimum 2-4 years’ experience in Clinical Research or clinical data management
- Experienced in Clinical Data Management processes, standards and clinical systems
- Experience working in Inform
- Exposure to Rave/ Veeva/ OC, e-Diaries, e-Source is an added advantage
- Proficient in Microsoft excel, visual basic and also validation methodology.
- Basic knowledge of PL SQL, SAS is an added advantage.
- Understanding of general data flow & database architecture concepts
- Good understanding of regulations consisting of ICH-GCP, 21 CRF part 11, CDISC requirement
- Comprehensive understanding of clinical drug/ Vaccine development process.
- Knowledge of medical terminology, anatomy as well as physiology.
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