Proven experience with numerous Clinical Data Management Systems (e.g., Medidata Clinical Cloud, eLluminate, Saama SDQ, etc.) and external clinical data sources (e.g., Lab, biomarker, eCOA, DTC, etc.)
As a Business Analyst, you will be spearheading the execution of critical digital projects in support of ambitious clinical digital roadmap. In this role, you will connect and lead various stakeholders and contributors to collaborate on digital clinical projects.
Responsibilities:
Heres What Youll Do
Proven experience with numerous Clinical Data Management Systems (e.g., Medidata Clinical Cloud, eLluminate, Saama SDQ, etc.) and external clinical data sources (e.g., Lab, biomarker, eCOA, DTC, etc.)
-Hands on knowledge of CSV concepts NOT A CSV person. Understands process and data workflow.
-Hands on knowledge of AI/ML model validation process a major plus.
-Tangible track record in using Agile approaches in a regulated environment.
You have first-hand and practical use of data integrity requirements for systems used in the conduct of clinical trials.
You have clinical operations, clinical data management, regulatory and safety business processes in a drug development context.
You work independently yet engage proactively with team members, colleagues and stakeholders to get alignment and drive projects forward.
Senior Business Analyst- Clinical Data Systems • Norwood, MA, United States
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