GSK Pharma Data Study Analyst Vacancy 2021 – Apply Online
Are you looking for an opportunity to support process improvement initiatives and share 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.
Job Title: Analyst, Study Data
Location: Bengaluru, India
Department: Medical and Clinical
Req Id: 289550
Eligibility Criteria:
They are looking for professionals with these required skills to achieve our goals:
- Master’s degree in Pharmacy Degree
- Understanding the clinical environment, complex processes, and 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 validation methodology.
- Basic knowledge of PL SQL, SAS is an added advantage.
- Understanding of general data flow & database architecture concepts
- Good understanding of regulations including ICH-GCP, 21 CRF part 11, CDISC requirement
- Comprehensive understanding of clinical drug /Vaccine development process.
- Knowledge of medical terminology, anatomy and physiology.
Responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- 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.
- Analyzing and resolving discrepancies identified by the programmatic checks within the eCRF system and during manual data review.
- 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.
- 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.
- Ability to handle multiple tasks and perform other duties as assigned by Study or Line Manager
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