INC ResearchProject Analyst
Apr. 2010 - Nov. 2011Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s). Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s). Participates in and presents at internal, customer, third-party and investigator meetings. Participates in internal/external audits. Develops User Test Plans for data entry screens, electronic edit checks, data listings, import / export programs and medical coding. Coordinates and supports release of tested clinical data databases to the production environment. Develops and/or delivers: a. eCRF training for CRAs and site staff ;
b. applicable data management departmental training related to technical processes and systems;
c. other project specific training. Develops and maintains CRF and eCRF Completion Guidelines (in consultation with clinical / customer team). Designs eCRF entry screens and associated eCRF visit structure, indexing and version control. Reviews
a. designs for CRF pages and eCRF entry screens and associated CRF / eCRF visit structures, indexing and version control, coordinating with team members responsible for the associated database design;
b. data Entry guidelines;
c. configurations of CRF WorkManager;
d. SAS Mappings (from CDMS Databases). Assists in the negotiation and contracting process with outside vendors such as e-CRF/Diary vendors, CRF Printer and IVRS vendors. Maintains documentation on an ongoing basis and ensures that all filing is up to date. Participates in the development of departmental technologies, SOPs, processes and procedures. Trains and mentors less experienced data management staff. Contributes to the Request for Proposal (RFP) and Request for Information (RFI) process. Prepares input for, and participates in proposal bid defense meetings.