Senior Analyst, Data Acquisition

GSK; Bengaluru; On-site; INR 900,000 - 1,500,000; Full time

Job summary

A global healthcare company based in Bengaluru is seeking a professional experienced in clinical data management. The role involves developing electronic data capture solutions and overseeing various data types for clinical studies. The candidate should have extensive knowledge of GxP and ICH requirements. This position will provide opportunities to improve processes and ensure quality control of deliverables within the drug development environment.

Qualifications

• Extensive working knowledge of GxP, ICH requirements, internal processes and external regulations that govern drug development.

Responsibilities

• Perform study setup activities and technical development of eDC solutions for clinical studies.
• Assist with vendor oversight of data types for clinical studies.
• Coordinate review and approval of study specification documents.
• Contributes to study design, protocol, planning and review of study documents.
• Coordinates review and approval of study specifications and vendor deliverables.

Skills

GxP knowledge

ICH requirements

Data quality control

Job description

Responsibilities

• Performs the study set-up activities and the technical development of Electronic Data Capture (eDC) solutions and associated tools for one or more clinical studies.
• Assist with the technical and vendor oversight of multiple data types for one or more clinical studies.
• Support the delivery of one or more clinical studies depending upon the phase, complexity, and similarity with support of junior data acquisitions staffs as required.
• Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate.
• Coordinates review, revision, and approval of study specification documents (including operational requirements & specifications) and/or key vendor deliverables (including translations).
• Understands, mediates and solves issues related to data acquisition; develops the study eDC application and associated documents including forms, data validation checks & data extraction and ensures delivery with quality and on time.
• Provides reports, status updates, feedback, and raises risks and advice to the Study Data Manager about study set-up and/or vendor related activities.
• Ensures quality control of deliverables.
• Provides inputs to process improvements, new processes, training, quality assessments, audits and inspections related to the Data Acquisition.
• Responsible for performing after-action reviews (success or failure) to share learnings and propose improvements for the future.
• Extensive working knowledge of GxP, ICH requirements, internal processes and external regulations that govern drug development (where applicable).

Qualifications

• Extensive working knowledge of GxP, ICH requirements, internal processes and external regulations that govern drug development (where applicable).

Additional information

Inclusion at GSK: As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at [e-mail] to discuss your needs.