Clinical Data Manager

Cardiovascular Research Foundation is dedicated to enhancing and saving patient lives through research. They are seeking a Clinical Data Manager responsible for ensuring the timely and accurate delivery of clinical study data.

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

Preferred

• Experience building EDC databases in Mednet, Medidata or other systems
• Basic SAS programming skills
• Experience with CDASH/CDISC standards
• EDC database building
• Mednet experience
• Medidata experience
• SAS programming
• CDASH standards
• CDISC standards

Benefits

• Choice of health plans include medical, Dental, and vision coverage
• Company-paid short-term and long-term disability and life insurance
• Health and dependent care flexible spending accounts
• Pre-tax travel expenses through TransitChek program
• 401(k) plan
• Generous paid time off (PTO)
• Ten paid holidays each year

Company

• Nonprofit interventional cardiovascular research and education organization
• New York, New York, USA
• http://www.crf.org/
• Founded in 1991
• 51-200 employees

Qualifications

• Bachelor's degree
• 2-3 years of clinical data management experience
• 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
• Experience building EDC databases in Mednet, Medidata or other systems
• Basic SAS programming skills
• Experience with CDASH/CDISC standards

Required skills

• 21 CFR Part 11, CDASH Standards, CDISC Standards, Clinical Data Management, EDC Databases, GCP/ICH Regulations, Medidata, Mednet, SAS Programming

Preferred skills

• Basic SAS programming skills, Experience with CDASH/CDISC standards

Experience

• 2-3 years