Job highlights

- Experience. 5+ years of data acquisition experience or related job experience in Clinical Research or Information Systems and / or relevant scientific experience.

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.

- 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, current 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).

- Experienced in eDC solutions (Inform, Rave, Veeva CDMS Vault) and ePro solutions.

- Knowledge of multiple programming languages (PL/SQL, SAS, Python, C#, etc.)

Experience

5+ years of data acquisition experience or related job experience in Clinical Research or Information Systems and/or relevant scientific experience.

Skills

- Electronic Data Capture (EDC)

- Clinical Data Management

- Data Management

- Data Validation

- Data Standards

- Clinical Information Systems

- Veeva

- Python (Programming Language)

- Clinical Trial Designs

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Sr Analyst, DA DS&M Data Acquisition (Bengaluru)
🏢 GSK India
📍 Bengaluru