Senior Analyst, DA DS&M Data Acquisition
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.
- For studies, key responsibilities include:
o Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate.
o Coordinates review, revision, and approval of study specification documents (including operational requirements & specifications) and/or key vendor deliverables (including translations)
o 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.
o Provides reports, status updates, feedback, and raises risks and advice to Study Data Manager about study set-up and/or vendor related activities.
o 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
Skills
Uniting science, technology and talent to get ahead of disease together.
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