The CDM Analyst ensures the successful end-to-end operation of clinical data transfer process including the successful design, configuration, deployment, and maintenance of the associated business tools and applications utilized in the clinical data management team. The role supports the optimal planning and execution of all data transfer activities, including super-user configurations, user acceptance testing and validation testing associated with the clinical tools in accordance with all applicable regulatory requirements.
This position will provide analytical support for incident and problem resolution as well as incident and problem intervention.
Delivers technical expertise in support of clinical data business applications and tools.
Executes configurations activities on defined applications environment.
Supports Clinical Data application with requirements gathering, preparation and execution of validation documents, user acceptance testing and work instructions.
Resolves incidents assigned by the Service Desk function, providing subject matter expertise during management of major incidents and problems for clinical data applications.
Assists in planning, testing, and implementation of changes to clinical data applications
Assists in QC and remediation activities as applicable
Writes documentation specific to the defined applications (e.g. work instructions, validation documentation).
Through experience in clinical data acumen, plans own work and adjusts efforts to meet goals
Through effective verbal communications skills escalate for resolution issues arising outside guidelines or operating procedures.
Utilizing strong time management and attention to detail skills take decisions with short-term impact independently, within a clear program of action and guided by precedence.
Key Performance Indicators/Measures of Success
Alignment with PMP Objectives
Supports business application validation activities as related to Clinical Data Management
Collects and prepares users requirements and design requirements
Authors technical and validation documents, including user requirements specifications (URS), performance qualification (PQ), work instruction (WI)
Execute validation documents as well as conduct user acceptance testing
Prepares and maintains application configuration, including metadata files and codelist files
Coordinates end-to-end delivery of validated MIRTH channels and configured LIMS exports for multiple projects with some guidance, ensuring quality deliverables on time
Communicates with Project Managers, MIRTH team, LIMS team and test method leads on a regular basis to meet data management deliverables on the multiple projects and ensures milestones meet timeline and quality deliverables
Handles confidential material and adhere to data security and confidentiality requirements
Communicates with data management staff regularly on data management issues
Participates in data transfer activities, including QC and remediation, using a GxP-compliant application like eInfoTree
Provides status updates related to project tasks to management as necessary
Troubleshoot Clinical Data Management related issues
Performs tasks as assigned to assist with the smooth operation of the Clinical Data Management team
Provides general support to Clinical Data Management staff and project management teams
Other Duties as assigned
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Education and Work Experience:
Master of Science with 1 year or Bachelor of Science with 2 years or minimum of 3 years direct Clinical Data Management or Clinical Research Associate experience
Knowledge of GxP and validation experience
Data analyst experience
User acceptance testing experience
Data application configuration experience
Clinical research and clinical trial experience preferred
Knowledge of eInfoTree and Mirth preferred
LIMS experience preferred
Good computer skills
* If a direct employer requests that you go to their web site and complete your application there in order to be
considered, please do so. Applications for all positions are subject to each employer's specific requirements.