Trial Data Manager leads Data Management activities for assigned trials and ensures compliance with standards, regulations, and timelines. The role coordinates eCRF development, data review and query management, database lock, and SDTM deliverables. The role includes collaboration with Clinical Development stakeholders, overseeing documentation and quality control, and management of outsourced partners when applicable. The position also forecasts resources, ensures team training, and assumes Data Manager responsibilities when required.
Every day, we rise to the challenge to make a difference and here’s how the Trial Data Manager role will make an impact:
Ensures that Data Management (Biometry) activities (related to assigned trial) adhere to client Standards, and applicable regulations
Meets trial timelines in terms of Data Management deliverables
Ensures data handling consistency within allocated trial(s)
Leads Data Management activities for assigned trial
Provides Data Management input to the development of the trial protocol
Coordinates the development of the (e)CRF in line with Viatris Innovation standards
Writes all trial Data Management documents covering specifications for external data transfer, data cleaning and review tools that will be further provided to DATA MANAGEMENT PROGRAMMER(S) for development for the allocated trials(s)
Prepares and archives Data Management trial documentation
Organizes, monitors, and tracks the testing of data entry screens (eCRF layout), data cleaning / review tools, and their implementation in the production environment
Organizes, monitors, and tracks data cleaning, data review, query management, and database lock; makes sure processes are driven in collaboration with key Clinical Development (CD) stakeholders
Generates trial metrics and status reports
Represents Data Management at Clinical Trial Team (CTT) meetings
Presents trial related topics at CTT, Investigators and Monitors meetings
Manages and is accountable for Data Management activities in studies where Data Management is outsourced (insourcing/outsourcing partners’ management)
Participates in development and review of policies, Standard Operating Procedures (SOPs), and associated documents for Data Management
Represents Data Management in cross functional working groups related to the system / process
Forecasts trial team resource requirements
Ensures Data Managers assigned to trial have required training
Ensures annotated CRF is created, validated, and provided as per agreed timelines
Performs and/or coordinates Quality Control (QC): Periodic operational checks to verify that clinical data are handled according to protocol, applicable Quality System (QS) documents and GCP
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
A master’s degree in life sciences, mathematics, statistics, informatics or related disciplines is required.
3+ years of experience in pharmaceutical or Biotech industry within Clinical Research and/or Clinical Data Management with a strong level of functional expertise in Data Management is required.
Strong organizational and communication skills in English.
Good knowledge of international clinical research regulations and requirements (e.g., International Conference on Harmonization – Good Clinical Practice (ICH/GCP)).
Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report Form (CRF) design.
Ability to lead and coordinate the activity of DATA MANAGER(S) allocated to the same trial.
Good organizational and presentation skills.
Fluent in written and spoken English.
Sedentary - Minimal handling of light materials and tools, lifting up to 10 lbs. May involve walking or standing for brief periods of time.
#J-18808-Ljbffr