Senior Analyst Data Acquisition

GSK; Bengaluru; On-site; INR 900,000 - 1,800,000; Full time

Job summary

GSK in Bengaluru, India seeks a data management professional to support study set-up and the technical development of electronic data capture (eDC) solutions for one or more clinical studies. You will assist with vendor oversight, data types, and delivery across phases, helping ensure quality and on-time delivery.

Responsibilities include input to study design, review of study documents, and coordination of specifications and vendor deliverables, including translations where applicable.

Qualifications

• Experience with clinical data management and data transformation activities.
• Knowledge of data types and biomarkers used in clinical studies.
• Familiarity with GxP and ICH guidelines applicable to data management.

Responsibilities

• Performs study set-up activities and develops eDC solutions for clinical studies.
• Oversees vendor activities and data types across studies as needed.
• Supports delivery of multiple studies depending on phase and complexity.
• Contributes to study design, protocols, and review of study documents.
• Coordinates review and approval of study specifications and vendor deliverables.
• Develops the study eDC application and related documents with data validation checks.
• Provides reports, updates, raises risks, and advises Study Data Manager.
• Ensures quality control of deliverables.

Skills

Biomarkers

Clinical Data Management

Data Transformation Services

Data Types

Job description

Job Description:

Key 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 study(ies).
• Assist with the technical & vendor oversight of multiple data types for one or more clinical study(ies).
• 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 Study Data Manager about study set-up and/or vendor related activities.
• Ensures quality control of deliverables

For studies, key responsibilities include:

• 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 Study Data Manager about study set-up and/or vendor related activities.
• Ensures quality control of deliverables

Provide 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

Skills

Biomarkers, Clinical Data Management, Data Transformation Services (DTS), Data Types

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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.

Requirements: