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.
Requirements
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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