Clinical Data Specialist II (Contract - Office Based) - NCR

Novella Clinical Resourcing is seeking a Clinical Data Specialist II (Contract – Office Based):


The Clinical Data Specialist II (CDS II) independently plans, conducts andreports the data management portion of a project. The CDS II is familiar withand provides leadership on choosing best practices for data managementprocesses, including data integration models and methods. The CDS II holdsprimary responsibility for Clinical Data Management (CDM) deliverables, andoversees, provides guidance, and delegates tasks as needed. The CDS II mayperform other CDS responsibilities on a project.


The CDS II independently plans and manages all project related data managementactivities for smaller scale projects and/or is part of a data managementproject team and independently manages components of the project. TherapeuticArea Knowledge Maintains familiarity with knowledge of healthcare and researchdata that is collected in a therapeutic area.

Project Management Budget/Scope of Work

Reviews data management section of scope of work and protocol; providesfeedback.

Monitors project scope of work; notifies Program Manager of scope changes.

Creates and maintains projects of data management work. Maintainsaccountability to the Project Leader for data management deliverables andtimelines.

Meetings Independently leads internal and external project team meetings thatmay include other functional groups, sponsors and external stakeholders (e.g.,data management team meetings, on- line review).

Closeout Collaborates with project stakeholders on project lock requirementsand activities during the closeout phase.

Drafts, updates and maintains the project lock checklist throughout the life ofthe project.

Risk Assessment

Assesses data management project risks to timelines, scope and budgets;escalates to Project Leader and/or Program Manager.


Communicates effectively with project leader, project team, sponsor and projectstakeholders regarding project data management issues, expectations, andrequirements.

Timelines Develops and manages CDM project specific timelines (e.g. Go-Live,PGLC/PGLD). Data Coordination EDC Support Manages process in support of EDCaccount management on projects; these include the Authorized Site User List(ASUL) and the help desk issue management system (HDIMS) setup. Troubleshootsand resolve project integration issues (e.g., IVRS; XXXX- developed tools suchas SADI; data loading).

Resolves and triages project related issues.

Performs and coordinates project lock procedures for systems within the CDMS.

Provides content for project communications (e.g., articles and publications).Prepares and makes presentations at internal and external meetings, includinginvestigator meetings


Assists in preparing and conducting internal and external audits; providesinput to corrective action plans from audit; performs execution of correctiveaction.

Maintains familiarity with applicable regulations and guidance.

Project Documentation

Collaborates with stakeholders on Data Management Plan content. Authors andmaintains the Data Management Plan throughout the project.

Maintains project documentation in a central location for the duration of theproject; includes, but is not limited to, a project profile, specifications,testing documentation, project data management training, and project lockdocuments.


Trains users on the EDC system, applications, and other project related datamanagement activities.

Creates eCRF instructions, training materials and other applicable CDMSinstructions.

Technical CDMS Requirements

Collaborates with project stakeholders on requirements and workflow of the CDMS EDC Database Requirements Coordinatesdatabase design and data validation checks with project stakeholders.

Collaborates with project stakeholders on best practices for data cleaningrequirements and requirements for reports/views, listings, quality controlchecks, alerts, data reconciliations and integrations.

Develops, programs and unit tests prototype eCRF screens and data validationchecks.

Standards Collaborates with sponsor and statistician to implement appropriatecontrolled terminology, standards, or use of sponsor data structures.


Develops, updates and maintains specifications for project reports/views,listing, quality checks, alerts, data reconciliation requirements andintegrations; obtains approval from project stakeholders.

Defines the programming and testing schedule in collaboration with CDMTechnical Services and project stakeholders.

Creates, reviews and approves testing plan and testing results as required bythe project.

Authorizes release of components into the production environment.

Performs and documents quality control testing, user acceptance testing (UAT)and production qualification on components of the CDMS as required by theproject.

Coordinates UAT with project stakeholders.

Production Oversees data cleaning and data reconciliation process throughoutthe life of the project.

Manages defects, changes and deferred components of the CDMS.

Uses structured query language (SQL) to produce ad hoc reports for bothinternal and external stakeholders.

Oversees coordination of dataset exports with Data Export Services.Administrative Works with Program Managers to adequately resource projectneeds.

Participates in departmental initiatives. Coaches and helps provide support andguidance for new project team members on project tasks. Participates inperformance review via self-assessment, personal goal- setting, and providingfeedback about colleagues. Participates in interviewing hiring candidates.Evaluates coworkers# performance to provide input into annual evaluations.Provides input to Program Manager on training needs of the project team.Completes required XXXX, departmental and project training; maintains a workingknowledge of requirement trainings.


Work requires organizational, analytical and communicationsskills generally acquired through completion of a bachelor’s degree program.


Work requires three years of directly related data management experience


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