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.

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.

QUALIFICATIONS

• Bachelor’s degree
• 2-3 years of experience
• Experience building EDC databases in Mednet, Medidata or other systems preferred
• Basic SAS programming skills desired
• 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 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.

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

COMPENSATION

The hiring range for this position is $80,000 - $110,000 per year. The annual salary that will ultimately be offered to the successful candidate will depend on job-related knowledge, education, skills, and experience.

CONTACT INFORMATION

To be considered for this opportunity, please submit your resume.

Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day www.crf.org

CRF is an equal opportunity employer.

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