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).
location: Saint Paul, Minnesota
job type: Contract
salary: $40.00 - 47.19 per hour
work hours: 9 to 5
education: Bachelors
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.
qualifications:
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.
- Medical device, Pharma background
- programming knowledge or background
skills: CDISC, CRFs, Clinical Data Management, GCP (Good Clinical Practice), ICH Regulations, Good Clinical Practice (GCP), Good Documentation Practices (GDP)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
