Senior Business Analyst- Clinical Data Systems

Business Analyst

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:

• Coordinate and participate in requirement gathering and definition (Business Analysis) for Clinical Data Environment (CDE) – Data Checks and Cleaning, Conformed Data Store, and Statistical Computing Environment (SCE) projects
• Establish and manage project timelines and project deliverable
• Ensure project goals and means meet business objectives and deliver value in a timely fashion
• Work collaboratively across the organization to gain alignment on project objectives and deliverables
• Engage with Computer Systems Validation lead to support appropriate validation activities
• Report on project progress and status

Here’s What You’ll 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.