Clinical Data Manager

Junior Clinical Data Manager

This role is subject to a flexible hybrid work arrangement requiring a minimum of 2 pre-determined days per week in our mid-town office.

Summary

The Junior Clinical Data Manager is responsible for the tasks needed to ensure timely and accurate delivery of clinical study data.

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 test edit checks and performs database validation activities.
• 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.
• Assists in managing user access to EDC databases.
• Participate in study team meetings to provide ongoing data status.
• Demonstrates knowledge of GCP/ICH regulations and 21 CFR Part 11.
• Additional duties as assigned.

Qualifications

• Bachelor's degree
• Basic SAS programming skills desired
• Experience with CDASH/CDISC standards preferred.
• Experience building EDC databases desired.
• 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 the needs of the Data Management Department.
• 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 Data Management Department.
• Ability to analyze information and solve problems.

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)
• Fourteen paid holidays each year

Compensation

The hiring range for this position is $68,000 - $75,000 per year. The annual salary that will ultimately be offered to the successful candidate will depend on job-related knowledge, education, skills, and experience.

CRF is an equal opportunity employer.