Sr Analyst, DA DS&M Data Acquisition

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, 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).
• 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

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