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Data Analyst II Data Analyst II
Ref No.: 18-14520
Location: Bridgewater, New Jersey
JOB SUMMARY
The primary purpose of this role is to perform data management and support of drug projects for the Early Development studies under the responsibility of TMED and Preclinical Safety. 
The Early Development Data Manager role is responsible to provide data extractions, format transformations, data integrations and exchanges supporting drug project work for PKDM, BCB and Preclinical Safety departments of R&D.  Support scope is US, France, Germany and Asia Pacific TMED sites.
The role includes maintaining efficient procedures for data management, compliant with regulatory compliance expectations and principles.
 
Knowledge And Skills:
  • Process development and management
  • Document management, Microsoft Office tools (Excel, WORD primarily)
  • Understanding of CDISC data standards (SDTM and SEND)
  • Understanding in GxP and legal requirements for 21 CFR Part 11 and OECD
  • Strong collaboration competency
  • Quick comprehension and assertiveness
  • Excellent organizational and communication skills
Proficient in English, with French and German a plus.
 
Formal Education And/Or Experience Required:
  • Bachelor’s degree or higher in biology, computational sciences, technology
  • Minimum 3 years in pharmaceutical R&D environment, including GxP compliance
  • Toxicology, PK, PK-PD, Biological Analysis data management
  • International work experience a plus
  • Use of biotechnical instrument output and LIMS interfacing
  • Familiarity of nonclinical and clinical PK and bioanalysis laboratory application environments for data collection, analysis and reporting.
 
MAJOR DUTIES & RESPONSIBILITIES (what the job does)
Provide data management and programming skills to deliver and fulfill data management needs of project teams and analysts
  • Transform and curate data
  • Study metadata tabulation
  • Merge datasets
  • Prepare datasets for visualization, data exploration
Database upload
Support biomarkers/biological analysis, PK, PK-PD data provision process for both clinical and non-clinical studies
- Insure efficient data flow, following associated business processes between data capture to submission.
- Maintain training and ensure process understanding
- Monitor process usage and timeline commitments
- Support documentation maintenance and communicate with the user community
- Insure data delivery to data consumers