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Company Contact Info
- Trenton, NJ 08648
- Gabrielle Cruz
- Phone: 732-650-3015
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Clinical Data Manager
Joule • Trenton, NJ
Posted 2 months ago
Title: Clinical Data Manager
Location: Lawrence Twp., NJ
- The primary responsibility of the Clinical Data Manager will be to review all data management deliverables for CRO executed clinical studies within a specific drug development program.
- Comprehensive review of all CRO generated data management related documents, including Rave database specifications, CRF, DMPs, edit check/validation and manual data listing plans, external data specifications, database testing plans and results, monitoring plans, safety management plans, etc.
- Detailed review of the Rave study data through the Rave interface to identify data quality issues.
- Quality assessment of system and manual data query management for eDC and external data.
- Review of external vendor data from central labs, specialty labs, imaging vendors, eCOA data etc.
- For selected data quality issues complete a risk assessment including a root cause analysis.
- Detailed documentation of findings with proposed action plans.
- Review the use of standards across studies in the program, documenting differences.
- A minimum of 5 years clinical data management including expertise using Medidata Rave is required. Strong analytical skills and technical skills (i.e. excel or SAS) are essential.
- A minimum of 5 years as a clinical study data manager at a biotech, pharmaceutical company or CRO required.
- Safety laboratory data management experience required (Biomarker data knowledge a plus).
- CDISC CDASH knowledge required (SDTM and ADaM a plus).
- A high level of expertise using Microsoft Excel required (SAS is a plus).
- Strong written documentation skills required.
- Strong investigative and problem solving skills required (root cause analysis, audit experience and/or CAPA development a plus).
- Knowledge of current global GCP and DM best practices required (recent inspection experience a plus).
- Ability to read and interpret clinical study protocols required (experience reviewing statistical analysis plans a plus).
- Attention to detail and strong organizational skills required.
- Ability to work independently under limited guidance.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.