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Clinical Reporting Lead


  • Global Channel Management, Inc.
  • 03/25/20
  • Irvine, CA
  • 92612
  • $65 / Hourly
  • Contractor
Clinical Reporting Lead needs BS/BA degree with 6 years experience, or MS degree with min. 4 years of experience in Life Science, Computer Science, or related field required
Clinical Reporting Lead requires:
Strong Project Management and Communication skills
Strong knowledge of databases, such as Oracle
Knowledge of visualization tools, such as TIBCO Spotfire, etc.
Knowledge of clinical reporting tools (e.g. Cognos, J-Review, Power BI, SQL, PL-SQL, SAS, etc.)
Knowledge of industry specific data standards e.g., CDASH, CDISC ODM/SDTM
Intermediate knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies
Intermediate knowledge of Clinical Data Management and Clinical Programming methodologies as well as current and emerging global industry standards
Working knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.)
Intermediate knowledge of Research & Development (R&D) and an understanding of regulatory guidelines/requirements related to R&D (e.g., ICH, GCP, safety reporting)
Clinical Reporting Lead duties:
lead the design, development, validation, rollout of reports/dashboards using business intelligence tools (e.g., Spotfire, J-Review, Power BI) and programs (e.g., SQL, PL-SQL, R, SAS) used in Clinical Research and Development studies.
analyze Clinical Study design requirements against third party system specifications to support the implementation of electronic systems (e.g., electronic diaries) used in Clinical studies.
assist in the validation of electronic systems and programs as implemented internally or through external vendors according to current regulatory requirements.


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