Clinical Data Manager

at  Cardiovascular Research Foundation

SUMMARY

This position is responsible for the tasks needed to ensure timely and accurate delivery of clinical study data.

QUALIFICATIONS

• Bachelor’s degree
• 2-3 years of clinical data management experience
• Experience building EDC databases in Mednet, Medidata or other systems preferred
• Basic SAS programming skills a plus
• Experience with CDASH/CDISC standards preferred
• Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment. Must be able to prioritize
• Must be able to understand the expectations and daily workflow of the data management department
• Willingness and flexibility to occasionally work evenings and weekends to support needs of the Department Manager
• Ability to effectively communicate verbally with employees within a team, and outside vendors as required
• Ability to communicate effectively when reading and writing e-mail, memos and presentations on behalf of the Department Manager
• Ability to analyze information and solve problems

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Follow the processes set forth by the department SOPs and the study Data Management Plan to ensure the highest data quality within the organizations managed databases and for outsourced EDC databases.
• Develops and maintains data management plans, CRF completion guidelines and edit check specifications.
• Develops and tests edit checks.
• Performs study data discrepancy review and generates needed queries.
• Monitors study progress as it relates to study data and generates related reports.
• Tracks outstanding data queries and facilitates timely query resolution.
• Participates in study team meetings to provide ongoing data status.
• Demonstrates knowledge of GCP/ICH regulations and 21 CFR Part 11.
• Additional duties as assigned.