The Duke Clinical Research Institute in Durham, NC has an exciting opportunity for a experienced Clinical Data Specialist. The Clinical Data Specialist III (CDS III) independently plans, conducts and reports the data management portion of large, complex or international projects 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 projects, facilitating infrastructure initiatives and participating in business development activities. The CDS III may perform other CDS level and Program Manager responsibilities on a project.
The CDS III independently plans and manages all project related data management activities to include project contracts and sponsor communication. The projects include international with multiple collaborators, partners or sub-contractors, and projects involving new technology. Project Management Budget/Scope of Work Contributes to the data management portion of the scope of work and protocol.
Provides input and assistance to Program Manager for scope of work changes. Oversees projections for project data management work.
Maintains accountability to the Project Lead for data management deliverables and timelines. Manages internal and external customer expectations. Risk Assessment Proposes solutions to project risks; collaborates with the Project Leader and/or Program Manager to manage risk. Communication
Oversees communication with Project Leader, project team, sponsor and project stakeholders regarding project data management items. Timelines Oversees CDM project specific timelines.
Coordinates with cross-functional team to develop and manage project timelines. Data Coordination EDC Support Oversees processes in support of EDC account management on projects.
Oversees coordination and resolution of project integration issues. (e.g., IxRS, SADI, data load issues).Manages project related issues.
Oversees project lock procedures for systems within the CDMS (e.g., EDC database, integrations).Audits Supports internal and external audits; develops and oversees execution of corrective action plan.
Stays current with applicable regulations and guidance. Project Documentation Oversees creation and management of the Data Management Plan throughout the project; may include complex project plans.
Supervises maintenance of project documentation in a centralized location for the duration of the project; to include, but is not limited to, a project profile, specifications, testing, and project data management training. Meetings Directs internal and external project team meetings that may include cross-functional groups, sponsors and external stakeholders (e.g., data management team meetings, on-line review).
Work requires organizational, analytical and communications skillsgenerally acquired through completion of a bachelor's degree program.
Work requires four years of directly related data management experience.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE