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Clinical Data Specialist ()
Project Details: The client is a mid-sized, clinical research institute that is looking to bring on a clinical data specialist. This consultant will join the data management team helping to coordinate projects, as well as facilitating new initiatives and business development activities.
Must Have Skills:
• At least 5 years of experience with clinical data management
• Experience with large data projects running as a PM
• Lead experience within data
• Identify data trends and report these trends
•Experience with communicating data to the stakeholders
Day to Day Responsibilities:
Project Management
• 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.
• Proposes solutions to project risks; collaborates with the Project Leader and/or Program Manager to manage risk.
• Oversees communication with Project Leader, project team, sponsor, and project stakeholders regarding project data management items.
• Oversees DS project specific timelines.
• Coordinates with cross-functional team to develop and manage project timelines.
Data Coordination
• 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).
• Supports internal and external audits; develops and oversees execution of corrective action plan.
• Stays current with applicable regulations and guidance.
• 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.
• 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).
• Oversees collaboration on project lock requirements and activities during closeout.
• Supervises the management of the project lock checklist.
• Maintains a working knowledge of healthcare and research data that is collected in a therapeutic area.
• Oversees training on the EDC System, applications, and other project related data management activities.
• Clearly defines project specific expectations, roles and responsibilities for all data management team members.
• Oversees creation of eCRF instructions, training materials and other applicable CDMS instructions or other project related communication. Prepares and makes presentations at internal and external meetings, including investigator meetings.
Technical
• Oversees collaboration with project stakeholders on requirements and workflow of the CDMS (e.g., database, integrations, and systems).
• Oversees database design and data validation checks with project stakeholders.
• Supervises collaboration with project stakeholders on best practices for data cleaning requirements and requirements for reports/views, listings, quality control checks, alerts, data reconciliations and integrations.
• Develops, programs and unit tests prototype eCRF screens and data validation checks.
• Manages collaboration with sponsor and statistician to implement appropriate controlled terminology, standards, or use of sponsor data structures.
• Manages development, updates, and maintenance of specifications for project reports/views, listing, quality checks, alerts, data reconciliation requirements and integrations.
• Oversees the programming and testing schedule in collaboration with CDM Technical Services and project stakeholders.
• Supervises review and approval of testing plan and testing results, and release of components into the production environment.
• Oversees performance and documentation of quality control testing, user acceptance testing (UAT) and production qualification on components of the CDMS; oversees UAT with project stakeholders.
• Supervises all production activities on a project, including data cleaning, CDMS defects and changes, and data export services.
Remote, EST hours.
Must Have Skills:
• At least 5 years of experience with clinical data management
• Experience with large data projects running as a PM
• Lead experience within data
• Identify data trends and report these trends
•Experience with communicating data to the stakeholders
Day to Day Responsibilities:
Project Management
• 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.
• Proposes solutions to project risks; collaborates with the Project Leader and/or Program Manager to manage risk.
• Oversees communication with Project Leader, project team, sponsor, and project stakeholders regarding project data management items.
• Oversees DS project specific timelines.
• Coordinates with cross-functional team to develop and manage project timelines.
Data Coordination
• 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).
• Supports internal and external audits; develops and oversees execution of corrective action plan.
• Stays current with applicable regulations and guidance.
• 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.
• 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).
• Oversees collaboration on project lock requirements and activities during closeout.
• Supervises the management of the project lock checklist.
• Maintains a working knowledge of healthcare and research data that is collected in a therapeutic area.
• Oversees training on the EDC System, applications, and other project related data management activities.
• Clearly defines project specific expectations, roles and responsibilities for all data management team members.
• Oversees creation of eCRF instructions, training materials and other applicable CDMS instructions or other project related communication. Prepares and makes presentations at internal and external meetings, including investigator meetings.
Technical
• Oversees collaboration with project stakeholders on requirements and workflow of the CDMS (e.g., database, integrations, and systems).
• Oversees database design and data validation checks with project stakeholders.
• Supervises collaboration with project stakeholders on best practices for data cleaning requirements and requirements for reports/views, listings, quality control checks, alerts, data reconciliations and integrations.
• Develops, programs and unit tests prototype eCRF screens and data validation checks.
• Manages collaboration with sponsor and statistician to implement appropriate controlled terminology, standards, or use of sponsor data structures.
• Manages development, updates, and maintenance of specifications for project reports/views, listing, quality checks, alerts, data reconciliation requirements and integrations.
• Oversees the programming and testing schedule in collaboration with CDM Technical Services and project stakeholders.
• Supervises review and approval of testing plan and testing results, and release of components into the production environment.
• Oversees performance and documentation of quality control testing, user acceptance testing (UAT) and production qualification on components of the CDMS; oversees UAT with project stakeholders.
• Supervises all production activities on a project, including data cleaning, CDMS defects and changes, and data export services.
Remote, EST hours.