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Data Acquisition Specialist
Ref No.: 19-04199
Location: South San Francisco, California
This is an excellent opportunity to start a career with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients' lives! 

Duties:
  • The DAS is responsible for the specifications, acquisition, loading and delivery of non-CRF data including IxRS, laboratory, pK and other data.
  • Responsible for the production of non-CRF data collection specification documentation
  • Defines the study specific non-CRF data handling strategy
  • Collaborates with SMT to agree on vendor expectations for the collection and transfer of data
  • Reviews and refines the technical requirements with service provider to establish the transfer of non-CRF data
  • Responsible for establishing appropriate transfer methodology with external data provider
  • Provides transfer methodology training and documentation on non-CRF data for external vendors.
  • Responsible for configuring the data loading tools based on data collection specifications
  • Receives, uploads, confirms and communicates status of test data transfers to validate and accept file format and database structure
  • Performs verification and resolves data transmission, file format and loading errors with data providers
  • Proactively checks all inbound non-CRF electronic data for any potentially unblinding data as defined in the protocol and ensures study integrity by sequestering unblinding data until data release is authorised
  • Delivers data to external recipients and review bodies via established transfer methodologies
  • Represent CDM on IxRS sub teams and works with the Study Management Team to develop IxRS specifications and implement the system
  • Coordinates and plans subfunction activities to meet program-level deliverables and timelines
  • Develops and maintains the subfunction standards for the studies in a program
  • Collaborates with Data Modeling Specialists to define study data collection standards for new assessments and collaborates with them to implement new standards
  • Effectively communicates ideas, project goals and status of work and can present to senior management
  • Proactively develops solutions to complex problems requiring the regular use of ingenuity and innovation
  • Sets targeted timeframes for deliverables and anticipates potential scenarios that may result in timeline delays; able to influence and negotiate a positive outcome
  • Proactively develops contingency plans to reduce impact of risks that may occur, to analyze effectiveness of strategies and to monitor and review risks

Skills:
  • Requires a B.A./B.S. or equivalent with significant experience in one or more Clinical Data Management , Biometrics or relevant clinical development functions.
  • Knowledge of core clinical data management applications (Clinical data management systems, electronic data capture, query tools, web browser, MS Office suite).
  • Clinical data management system experience (EDC Medidata Rave preferred).
  • Ability to apply advanced principles, theories and concepts for CDM as a whole.
  • Understanding of the conceptual basis for data management conventions, standards and processes.
  • Good understanding of the role of data management, biostatistics and statistical programming in the drug development process.
  • Ability to develop solutions to complex problems.
  • Ability to grasp industry trends and apply them to work within the organization.
Education:
Requires a B.A./B.S. or equivalent with significant experience in one or more Clinical Data Management, Biometrics or relevant clinical development functions.