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Company Contact Info

  • Trenton, NJ 08648
  • Bridget Burns

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Clinical Data Manager

Alpha Consulting Corp. • Trenton, NJ

Posted 2 months ago

Job Snapshot

Biotechnology, Pharmaceutical

Job Description


Project Description:
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. The selected candidate will also work directly with the sponsor study team members to provide DM best practice SME support and guidance.
  • 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.

Required Skills:
  • A minimum of 5 years as a clinical study data manager at a biotech, pharmaceutical company or CRO required.
  • A minimum of 5 years clinical data management including expertise using Medidata Rave is required.
  • A minimum of 3 years working within Medidata Rave required (Rave study builder skills a plus).
  • 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.
  • Strong analytical skills and technical skills (i.e. excel or SAS) are essential.

This 6+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget:

Job ID: 19-00612
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