Clinical Data Specialist III (Office Based) - NCR
Novella Clinical Resourcing seeking Clinical Data Specialist III (Office Based):
TheXXXX Institute in Durham, NC has an exciting opportunity for an experiencedClinical 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 bestpractices for data integration processes. The CDS III provides the expertleadership for defining data management project requirements, considerationsand effective implementation options. The CDS III position is an experiencedmanager supporting Clinical Data Management (CDM) teams, coordinating projects,facilitating infrastructure initiatives and participating in businessdevelopment activities. The CDS III may perform other CDS level and ProgramManager responsibilities on a project.
The CDS III independently plans and manages all project related data managementactivities to include project contracts and sponsor communication. The projectsinclude international with multiple collaborators, partners or sub-contractors,and projects involving new technology. Project Management Budget/Scope of WorkContributes 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 deliverablesand timelines. Manages internal and external customer expectations. RiskAssessment Proposes solutions to project risks; collaborates with the ProjectLeader and/or Program Manager to manage risk. Communication
Oversees communication with Project Leader, project team, sponsor and projectstakeholders regarding project data management items. Timelines Oversees CDMproject specific timelines.
Coordinates with cross-functional team to develop and manage project timelines.Data Coordination EDC Support Oversees processes in support of EDC accountmanagement 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 andoversees execution of corrective action plan.
Stays current with applicable regulations and guidance. Project DocumentationOversees creation and management of the Data Management Plan throughout theproject; may include complex project plans.
Supervises maintenance of project documentation in a centralized location forthe duration of the project; to include, but is not limited to, a projectprofile, specifications, testing, and project data management training.Meetings Directs internal and external project team meetings that may includecross-functional groups, sponsors and external stakeholders (e.g., datamanagement team meetings, on-line review).
Oversees collaboration on project lock requirements and activities duringcloseout. Supervises the management of the project lock checklist. TherapeuticArea Knowledge Maintains a working knowledge of healthcare and research datathat is collected in a therapeutic area. Training Oversees training on the EDCSystem, applications, and other project related data management activities.
Clearly defines project specific expectations, roles and responsibilities forall data management team members.
Oversees creation of eCRF instructions, training materials and other applicableCDMS instructions or other project related communication.
Prepares and makes presentations at internal and external meetings, includinginvestigator meetings.
Technical CDMS Requirements
Oversees collaboration with project stakeholders on requirements and workflowof the CDMS (e.g., database, integrations, systems).EDC Database Requirements
Oversees database design and data validation checks with project stakeholders.Supervises collaboration with project stakeholders on best practices for datacleaning requirement sand requirements for reports/views, listings, qualitycontrol checks, alerts, data reconciliations and integrations.
Develops, programs and unit tests prototype eCRF screens and data validationchecks. Standards Manages collaboration with sponsor and statistician toimplement appropriate controlled terminology, standards, or use of sponsor datastructures.
Manages development, updates, and maintenance of specifications for projectreports/views, listing, quality checks, alerts, data reconciliationrequirements and integrations.
Oversees the programming and testing schedule in collaboration with CDMTechnical Services and project stakeholders. Supervises review and approval oftesting plan and testing results, and release of components into the productionenvironment.
Oversees performance and documentation of quality control testing, useracceptance testing (UAT) and production qualification on components of theCDMS; oversees UAT with project stakeholders.
Supervises all production activities on a project, including data cleaning,CDMS defects and changes, and data export services.
Works with Program Managers to adequately resource project needs. Leadsdepartmental initiatives. Coaches, mentors, and helps provide support to newproject team members on project tasks.
Participates in screening, interviewing and hiring of team members.
Participates in performance review via self-assessment, personal goal-settingand providing feedback about colleagues. Evaluates coworker’s performance toprovide input into annual evaluations.
Completes required XXXX, departmental and project training; maintains a workingknowledge of requirement trainings.
Work requires organizational, analytical and communications skills generally acquired through completion of a bachelor’s degree program.
Work requires three years of directly related data management experience
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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