Associate Director, Clinical Data Management Systems Integration


Thorough knowledge of clinical trial study design, data collection and the drug development process
Ability to manage multiple complex projects and assess resource needs
Excellent verbal and written communication skills
Background in designing visualization tools in a clinical trial data visualization environment
Experience with CDASH standards
Familiarity with clinical data sets from major EDC systems (e.g., Medidata Rave, InForm, TrialMaster), safety systems (Argus), and CTMS systems.
Understanding of clinical data structures, relational database structures, and data exchange
In depth understanding of regulatory, industry (GCP), and technology standards and requirements [ICH E6 and Regulatory Guidelines and SDLC]
Strong project management skills and ability to work in a cross-functional team environment
Knowledge of ICH E6 (R2) Risk Based Monitoring a plus
Experience with SAS, T-SQL, and Qlik is a plus
Required: Bachelor or Master's Degree in Biology, Mathematics, or related fields
Preferred: 10 years in a clinical trial role including 3 years minimum of line management and leadership responsibilities. 


Palo Alto, California 94020




Pharmaceutical Preparations


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