Colorado Energy Jobs

Colorado Jobs

Job Information

Clovis Oncology, Inc. Manager, Clinical Data Systems and Programming in Boulder, Colorado

Job Summary

The Manager of Clinical Data Systems and Programming will work closely with biostatistics, data management, clinical development and clinical operations colleagues to oversee the creation and maintenance of the CRFs in the Medidata Rave systems. In addition, the manager will oversee the URL maintenance, validation, system administration, and training.

Responsibilities

  • Manages service providers to ensure the quality of deliverables and that timelines are met.

  • Liaise cross functionally with internal counterparts to develop standard case report forms and edit check specification.

  • Develops and maintain the Global Library in Rave.

  • Responsible for building effective Data Management vendor relationships for the EDC system. Escalate issues with proposed solutions, as necessary.

  • Develop, program, test and maintain data review listings in Jreview and/or SAS for data review purposes.

  • Oversee training and qualification of all users including the maintenance of appropriate documentation.

  • Lead the development of URL management and clinical programming SOPs and the development/optimization of clinical process from study start up to database lock.

  • Contributes to technical infrastructure of Data Management and process improvement.

  • Provides real-time technical support to Data Management team

  • Ability to manage multiple priorities and effectively communicate technical issues to all employees

  • Other duties as assigned

Education and Experience

  • Bachelor’s degree in Computer Sciences, Mathematics, Life Sciences with a minimum of 7 years of data system experience in the pharmaceutical or biotechnology industry, or MA/MS with 3 years of experience plus 1 year of people management experience

  • Oncology experience required

  • Excellent written and oral communication skills

  • Hands-on study management experiences with IMedidata RAVE.

  • Standardized data analysis of clinical data

  • Generation of quality assurance summary tables and listings.

  • Strong computer skills with proficiency in Medidata Rave and MS Office.

  • Working experience with CDISC / SDTM preferred

    Working Conditions

  • Office-Based position. Some travel may be required.

Education and Experience

  • Bachelor’s degree in Computer Sciences, Mathematics, Life Sciences with a minimum of 7 years of data system experience in the pharmaceutical or biotechnology industry, or MA/MS with 3 years of experience plus 1 year of people management experience

  • Oncology experience required

  • Excellent written and oral communication skills

  • Hands-on study management experiences with IMedidata RAVE.

  • Standardized data analysis of clinical data

  • Generation of quality assurance summary tables and listings.

  • Strong computer skills with proficiency in Medidata Rave and MS Office.

  • Working experience with CDISC / SDTM preferred

    Working Conditions

  • Office-Based position. Some travel may be required.

DirectEmployers