​​​​Anayansi

~ Experience of supporting/using Oracle Inform , Central Designer, InForm Architect

~ Solid technical background and computer proficiency in a variety of databases and software applications; technical aptitude

~ Solid knowledge of clinical development processes and procedures, including related functional areas and regulations

~ Ability to work on complex or multiple project assignments

~Experience in one or more of the following technologies

• Oracle (database programming / query skills)

• Medidata Rave

• SAS

• Electronic Data Capture (Openclinica, Cmed, Rave, InForm)

~ Facilitate the resolution of technical problems relating to clinical trial systems either directly or indirectly via internal or external partners

~ Continuously improving systems and workflows to deliver clinical trial improvements

• time/cost/quality 

~ Ensure that clinical trial systems conform and remain compliant with regulatory validation requirements

• ICH GCP, FDA CFR Part 11

~ Several years experience actively supporting clinical trial study teams

~ Provide advice and support to Data Quality Leads regarding missing queries, missing data, or other data questions during the processing/data clean-up of InForm data, Rave and other EDC tools

~ Develop a working knowledge of systems that interface with Inform and collaborate with peers to resolve issues that cross a number of technical and process boundaries

~  Provide SQL programs to extract underlying InForm data to help diagnose issues

~ Point of contact for questions related to assigned functional areas and areas of expertise for internal and external customers

~ Design, develops and issues newsletters, best practices, cheat cheat, checklists

~Train less experienced personnel in the policies, procedures, and software used by department.

Additional information can be found on http://edcdeveloper.wordpress.com/curriculum-vitae/ or upon request