Job Description

Job Title: Clinical Data Specialist

Duration: 12+ Months (Possible extension)

Location: Arden Hills, MN 55112

Hybrid Role

Responsibilities:

• Responsible for ensuring the quality and integrity of clinical data via the creation of tools such as data collection instruments, data management plans, database specifications, and edit checks, as well as the review of clinical data for completeness, accuracy, and consistency.
• Collaboration with clinical colleagues (e.g., Project Management, Trial Operations, Site Operations, Clinical IS, Global Safety, Biostatistics, Quality and Medical Sciences) and other cross functional team members (e.g., Legal and Regulatory).
• Review clinical data for completeness, accuracy and consistency in accordance with the investigational plan.
• Develop and maintain data management documentation and guidelines in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP).
• Provide subject matter expertise to project team members during all phases of project life cycle.
• Provides accurate and timely clinical data to internal and external customers upon request.
• Develop, test, and maintain data management systems.
• Provide subject matter expertise prior, during and post internal and external audits and inspections.
• Maintain compliance with corporate, core and study-specific learning requirements.

Education/Experience:

• 2 - 4 Years exp with life sciences BS degree or 1 - 2 Years exp with MS degree.
• Someone with an eagerness to learn!
• Familiar with EDC (Electronic data capture) systems and SAS software
• Someone recently working within data management
• Data listings
• Query management experience
• Familiar with reviewing clinical documentation

Preferred:

• Medical device or Pharma background
• Programming knowledge or background

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