CLINICAL DATA SPEC III, DCRI
Duke University and Duke University Health System - Durham, NC

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OCCUPATIONAL SUMMARY
The CDS III independently plans, conducts and reports the data management portion of a large, complex or international project and provides leadership on the value and best practices for data integration processes. The CDS III provides the expert leadership for defining data management project requirements, considerations and effective implementation options.
The CDS III position is an experienced manager supporting Clinical Data Management (CDM) teams , coordinating several or large projects, facilitating infrastructure initiatives and participating in business development activities.
Expectations for this position include competency of the skills associated with the lower level Clinical Data Specialist position(s).
Individuals are expected to independently perform all job responsibilities within one year of entering the position. Additional duties may be assigned.
The CDS III reports to a Program Manager, Clinical Data Management.

WORK PERFORMED
Project Management
Independently plan and manage data management activities from project contracts and sponsor communication. The CDS III manages complex projects including international projects, projects with multiple collaborators, partners or sub-contracts, and projects involving new technology.
Scope Definition and Management
  • Contribute to definition of theproject scope of work.
  • Contribute to new project descriptions and scope of work.
  • Assist in selecting external vendors.
  • Write data related scope of work for sub-contracts.
Process Design, Management and Documentation
  • Oversee the design management and documentation of projects.
  • Perform Project Leader role when primary DCRI service is Data
Management support.
  • Manage vendors providing services for a research project.
  • Approve corrective action plans from external audits.
Capacity Planning and Fiscal Responsibility
  • Lead Internal CDM initiatives.
Technical
The CDS III independently designs and manages data management
operations for complex projects
including multiple external collaborators or sub-contracts, new data
standards, new technology or
new therapeutic areas.

CRF Design
  • Consult with external and internal parties to recommend the optimal
data collection strategies for
trials.
  • Research new therapeutic areas to develop working knowledge of
healthcare and research data
collected.

Data Management Operations
  • Lead the development and maintenance of systems used to support
project infrastructure.
  • Works with CDSs in study start up to design work process and system
needs based on sponsor
requirements.

Coding
  • Work out and designs coding processes when coding is done outside of
normal systems.
Data Cleaning
  • Create novel test strategies for testing highly modified Clintrial
functionality.

Data Transfers, Loading and Integration
  • Work with IT to perform UAT on new software.
  • Independently develop and coordinate aspects of esource/electronic
data transmissions.
  • Design documentation for data transfers inand out of DCRI.
Clinical Event Classification
  • Work with internal and external parties to design Clinical Events Classification (CEC) process.
  • Work with external parties to agree on logic to trigger suspected events, referential integrity of CEC data, data listings for CEC adjudicators, and Status reports, including data referential integrity, format, contents and schedule. Minimum Qualifications
Education Work requires organizational, analytical and communications skills generally acquired through completion of a bachelor's degree program.
Experience Work requires four years of directly related data management experience. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Duke University and Duke University Health System - 22 months ago - save job
About this company
Duke University Health System is a world-class health care network dedicated to providing outstanding patient care, educating tomorrow's...