Clinical Data Management Specialist
Clinical Data Management Specialist
Green Key Resources
United States
See who Green Key Resources has hired for this role
- Analyze protocols to develop study specific case report forms.
- Build and maintain CRFs and associated edit checks in Medidata Rave system.
- Oversee database validation and perform system migrations.
- Manage lab reconciliation process for specimen tracking and clinical datasets.
- Develop, maintain, and monitor unit study timelines for data management deliverables and milestones.
- Provide ideas and direction to document systems and processes that standardize and improve data
- quality and validity.
- Author CRF completion guidelines and data management plan.
- Generate reports and manage data discrepancies and reconciliation.
- Provide EDC site/user administration and support.
- Participate in infrastructure development, including the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Provide ideas and direction to document systems and processes that standardize and improve data quality and validity.
- Bachelor’s Degree in scientific discipline or related field.
- Minimum of six (6) years of experience in clinical study operations, including four (4) years of clinical data management.
- Minimum four (4) years of experience creating specifications for all aspects of a database build.
- Minimum (2) years database build experience in Medidata Rave required.
- Understanding of programming & relational database principals.
- Master’s Degree in scientific discipline or related field
- Experience in SQL Server.
- Advanced SQL query skills.
- Applied knowledge of CDISC/CDASH/SDTM.
- Experience with clinical dictionaries; MedDRA and WHO dictionaries.
- Applied knowledge of Medidata Coder.
- Experience in LabKey
- Knowledge of Good Clinical Data Management Practice (GCDMP) and Good Clinical Practice (GCP) guidelines.
- Knowledge of medical terminology.
- Understanding of clinical study operations.
- Strong written and oral communication skills.
- Strong analytical and problem-solving skills.
- Strong interpersonal skills.
- Strong organizational skills, and the ability to effectively manage multiple projects with competing priorities/deadlines while paying attention to detail.
- Able to work collaboratively in a team environment.
- Able to work independently, with minimal supervision.
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Research, Analyst, and Information Technology -
Industries
Staffing and Recruiting
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