AbbVie
Systems Design Analyst I, eCOA / ePRO (On-Site, IL Based)
AbbVie, Chicago, Illinois, United States,
Job Description
Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Creates the clinical technology design specifications (e.g., EDC, IRT, ePRO) for all assigned trials Creates the data cleaning plan for all assigned trials
Manages the work of the Query Analyst, or an outsourced trial support team, in the execution of the data cleaning plan Updates the data cleaning plan as necessary during trial conduct for all assigned trials Manages the execution of all DSS processes involved in the locking of the trial database for assigned trials Liaises with the study team. Effectively communicates progress and expectations around DM Operations processes and the health of the Study
Accountable to correctly implement the design of the protocol into the clinical technology design specifications for all assigned trials Accountable to produce a data cleaning plan that, when executed as designed, will produce a clinical-trial database that is fit for purpose and adequate for statistical analysis. Accountable for the timely application and implementation of the data cleaning plan across the data collected for assigned trials.
Accountable for the lock of assigned trial databases in a regulatory-compliant manner and in accord with DS SOPs, process design and timelines Accountable for supporting and utilizing Data Sciences policies and procedures.
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Creates the clinical technology design specifications (e.g., EDC, IRT, ePRO) for all assigned trials Creates the data cleaning plan for all assigned trials
Manages the work of the Query Analyst, or an outsourced trial support team, in the execution of the data cleaning plan Updates the data cleaning plan as necessary during trial conduct for all assigned trials Manages the execution of all DSS processes involved in the locking of the trial database for assigned trials Liaises with the study team. Effectively communicates progress and expectations around DM Operations processes and the health of the Study
Accountable to correctly implement the design of the protocol into the clinical technology design specifications for all assigned trials Accountable to produce a data cleaning plan that, when executed as designed, will produce a clinical-trial database that is fit for purpose and adequate for statistical analysis. Accountable for the timely application and implementation of the data cleaning plan across the data collected for assigned trials.
Accountable for the lock of assigned trial databases in a regulatory-compliant manner and in accord with DS SOPs, process design and timelines Accountable for supporting and utilizing Data Sciences policies and procedures.
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)