RBQM Programmer

RBQM Programmer

Prepare documentation of Risk Based Quality Management · Populate overarching RBQM documentation template with study specific activities to define which, Preferred Provider, or Clinical-CRO, will be completing tasks. · Interact with Internal or Preferred Provider Data Management and/or Statistical Programming to provide defined Central Statistical Monitoring (CSM) outputs. · Interact with GCO and Clinical-CRO to build conduit for information flow from CSM processing to enact dynamic changes in risk-based monitoring (RBM)

Review provided outputs · Review CSM outputs and/or Preferred Provider reports to identify emerging signals · Consolidate RBQM, DM (IDPR), and Biostatistics (DSP) signals into a common Risk Log (RIM or similar). · Ensure other functions, including GCO, Medical Monitor/ClinDev, Clinical Science, and Clinical-CRO populate findings into the same RIM central system. · Mine the central RIM for patterns, trends, and categorize · Advise RBQM Lead and study team of emerging signals that need to be triaged

Support RBQM initiatives · Develop with RBQM leadership additional SOP Associated Documents to define new processes · Conduct training for BDM and stakeholders

Qualifications

Bachelors (MS preferred) in in biology, pharmacy, nursing, or other scientific discipline

7+ years of related pharmaceutical industry or Clinical Research Organization experience

2+ years in roles related to risk management / RBQM activities, or biostatistics, or data management, or clinical operations, or similar