Description
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. Ability to multi-task and effectively set own priorities. Strong organizational skills. Strong communication and interpersonal skills.
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.
To find out more about Real please visit www.realstaffing.com