Medical Data Specialist

Medical Data Specialist
Hybrid - 3 days onsite/AH
Duration: 12 Months+
Shift: 1st Shift (08:00:AM - 04:30:PM)
Pay Range $36.46- $46.56

HM Note:

• Someone with an eagerness to learn!
• Familiar with EDC systems and SAS software
• Someone recently working within data management
• Data listings
• Query management experience
• Familiar with reviewing clinical documentation

Job Purpose:
Medical Data Specialists are 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. Medical Data Specialists achieve this through 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).

Work with a team of 10
Global Clinical Operations-

Responsibilities:
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.

Experience Required:
2 - 4 Years exp with life sciences BS degree or 1 - 2 Years exp with MS degree.
A developing professional.
Working knowledge and application of business and technical concepts, procedures and practices.
General knowledge of industry practices, techniques, and standards.
General understanding of business unit/group function.
Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.

Preferred:
Medical device, Pharma background
programming knowledge or background