Clinical Data Manager

Cardiovascular Research Foundation • New York, NY

19h • $80,000 - $110,000 • Hybrid

About The Position

This role is subject to a flexible hybrid work arrangement requiring a minimum of 1-2 pre-determined days per week in our mid-town office. SUMMARY This position is responsible for the tasks needed to ensure timely and accurate delivery of clinical study data. SUPERVISORY RESPONSIBILITIES This position does not manage direct reports, however this position shares knowledge with other department personnel, may orient and train new personnel and may assist with the delegation of tasks and responsibilities with project work.

Requirements

• Bachelor’s degree
• 2-3 years of 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 CRF employees 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.

Nice To Haves

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

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees