Senior Analyst, Data Acquisition

Key Responsibilities

• Perform 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, 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).

Skills

• Agile Thinking
• Clinical Data Management
• Clinical Development
• Clinical Information Systems
• Clinical Trial Designs
• Communication
• Creativity
• Data Analysis
• Data Management
• Data Standards
• Data Validation
• Influencing Without Authority
• Risk Management
• Stakeholder Management
• Teamwork

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