Job Description

Clinical Data Management SpecialistThis 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.This position is responsible for the tasks needed to ensure timely and accurate delivery of clinical study data.Essential Duties And ResponsibilitiesFollow 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.QualificationsBachelor's degree2-3 years of clinical data management experienceExperience building EDC databases in Mednet, Medidata or other systems preferredBasic SAS programming skills a plusExperience with CDASH/CDISC standards preferredStrong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment. Must be able to prioritizeMust be able to understand the expectations and daily workflow of the data management departmentWillingness and flexibility to occasionally work evenings and weekends to support needs of the Department ManagerAbility to effectively communicate verbally with employees within a team, and outside vendors as requiredAbility to communicate effectively when reading and writing e-mail, memos and presentations on behalf of the Department ManagerAbility to analyze information and solve problemsBenefitsChoice of health plans include medical, Dental, and vision coverageCompany-paid short-term and long-term disability and life insuranceHealth and dependent care flexible spending accountsPre-tax travel expenses through TransitChek program401(k) planGenerous paid time off (PTO)Ten paid holidays each yearCompensationThe 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.To be considered for this opportunity, please submit your resume.CRF is an equal opportunity employer.

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