Sr. Clinical Data Manager
Job post date: 06/20/2022

Sr. Clinical Data Manager, MS. Deg. in Pharmaceutics, Statistics., w/ 6 months of exp.; Lead data management tasks to examine data management processes to identify erroneous, missing, incomplete or implausible data including but not limited to development of Case Report Forms (CRFs), database specifications, Data transfer guidelines, Data base Cleaning Plan & execute Study Specification Worksheet (SSW); Design, develop, and maintain integrations, automations & applications using variety Application Program Interface (API) for clinical data systems including Electronic Data Capture (EDC), CTMS & eTMF; Architect, design, create, configure various clinical study databases & systems such as Medidata RAVE, Inform, Medrio, Oracle Clinical, IBM Clinical development based on software development lifecycle procedures such as Water fall and Agile methodologies, including requirements gathering, design, development, Testing and Production; Develop ad-hoc reports with Clinical data base integrated reporting tools using Tableau, PowerBI or JReview; Perform database development, including code-level development for edit check programming and entry screen programming and conduct data review, query generation/resolution, data coding, electronic data reconciliation and identification of protocol deviations; Develop solutions for data from data formats, mapping to standard structure that includes Medical Coding dictionaries such as MedDRA (Medical Dictionary for Regulatory Activities), and WHODD (WHO Drug Dictionary) and develop dashboards and analytics; Perform User Acceptance Test (UAT) of database or case report files, user roles and system checks for all assigned trials not only during the study start but also during the migrations/updates up to the data base lock; Review UAT findings with broader data management team and work with clinical database programmers to fix issues; Integrate various Randomization and Trial Supply Management (RTSM)/Interactive Web Response System (IWRS) tools, eConsent and electronic Patient Reported Outcomes (ePRO) systems within the databases using APIs; Skills: CRF, SSW, API, EDC, CTMS, eTMF, Medidata RAVE, Inform, Medrio, Oracle Clinical, IBM Clinical , Tableau, PowerBI, JReview, UAT, RTSM, & IWRS.

 

Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting.

 

Send Resume to Skill Buddy Inc, 1135 Kildaire Farm Road, Suite # 200,  Cary,  NC, 27511.