Overview
Senior Analyst in GSK's Data Acquisition (DA DS&M) team, responsible for electronic Data Capture (eDC) study set-up and technical development for one or more clinical studies.
What you'll do
- Perform study set-up activities and technical development of eDC solutions and associated tools for one or more clinical studies.
- Assist with technical and vendor oversight of multiple data types for one or more clinical studies.
- Support delivery of one or more clinical studies depending on phase, complexity and similarity, with support of junior data acquisition staff as required.
- Provide input to study design, the clinical protocol, study planning and review of study documents as appropriate.
- Coordinate review, revision and approval of study specification documents (including operational requirements and specifications) and/or key vendor deliverables (including translations).
- Understand, mediate and solve issues related to data acquisition.
- Develop the study eDC application and associated documents, including forms, data validation checks and data extraction, ensuring delivery with quality and on time.
- Provide reports, status updates, feedback, and raise risks and advice to the Study Data Manager on study set-up and/or vendor-related activities.
- Ensure quality control of deliverables.
- Provide input to process improvements, new processes, training, quality assessments, audits and inspections related to data acquisition.
- Perform after-action reviews (success or failure) to share learnings and propose improvements for the future.
What you'll need
- 5+ years of data acquisition experience or related job experience in clinical research or information systems and/or relevant scientific experience.
- Extensive working knowledge of GxP, ICH requirements, internal processes and external regulations governing drug development (where applicable).
- Experienced in eDC solutions (Inform, Rave, Veeva CDMS Vault) and ePro solutions.
- Knowledge of multiple programming languages (PL/SQL, SAS, Python, C#, etc.).
Details
- Location: Bengaluru Luxor North Tower.
Read the full description and apply on the company’s own careers page.