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Senior Clinical Data Manager, Clinical Data Management

Job Description:

Ensures optimized data collection, flow and access across EDC and non-EDC data sources. Ensures the quality and integrity of clinical data via the creation of tools such as data collection instruments, data management plans, database specifications, and edit checks, as well as the review of clinical data for completeness, accuracy, and CDISC regulatory compliance of Corcept clinical databases


Responsibilities:

  • Provides strategic input into the design of data flow across EDC and non-EDC data sources across vendor network
  • Manages data management service providers to ensure the quality of deliverables and that timelines are met
  • Contributes to the design of processes enabling near-real time data access for Corcept clinical trials
  • Ensure data quality of clinical database through implementation of CDISC compliance
  • Reviews and critically assesses data query resolution metrics and suggests process improvement
  • Reviews study protocols to ensure that data collection and CRF design meet study objectives
  • Performs SAE reconciliation between clinical and pharmacovigilance database
  • Review clinical data for completeness, accuracy and consistency in accordance with the investigational plan.
  • Provide subject matter expertise to project team members during all phases of project life cycle.
  • Provides accurate and timely clinical data to internal and external customers upon request.
  • Manage development, test and maintain data management systems.
  • Provide subject matter expertise prior, during and post internal and external audits and inspections.
  • Maintain compliance with company and study-specific learning requirements.


Requirements:

  • B.Sc/B.A or higher in science, math or computer science
  • 8+ years’ experience in pharma or biotech industry
  • 5+ years’ experience in data management in pharma or biotech industry
  • Experience with Oncology clinical trials and CDISC therapeutic area standards a plus
  • Experience with management of data flow and curation of biomarker data a plus
  • Experience managing Data Management CROs


Preferred Skills, Qualifications, or Technical Proficiencies:

  • Relational database experience, SQL, SAS, and clinical data management systems
  • Knowledge and experience with MedDRA, WHODrug and other Thesaurus classification of controlled management systems
  • Knowledge of CDISC/SDTM. Hands-on experience preferred
  • Hands-on experience working with mainstream EDC systems (e.g. Rave, Medrio, Inform)
  • Familiarity with Data Visualization Tools for quick customized data access (e.g. Spotfire, Tableau, RShiny) a plus
  • In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11
  • Demonstrated ability for project management of Data Management Deliverables in clinical development


If you are interested, please submit your resume by email to careers@corcept.com

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