Title: Sr. Clinical Data Manager

REQUIREMENTS: Master’s degree in Public Administration, Health Administration with 1 year experience.

Job Location: 114 Crockett Rd, King of Prussia, PA 19406

PRE REQUISITES:

• Conduct clinical data management activities for oncology clinical trials in accordance with clinical Practices (GCPs) guidelines and company Standard Operating Procedure (SOPs)
• Review clinical research study protocols & design of clinical database structure and case report forms (CRFs) consistent with Clinical Data Interchange Standards Consortium (CDISC) and Clinical Data Acquisition Standards Harmonization (CDASH) Guidelines.
• Develop edit check specifications, test plan, test scripts, and perform User Acceptance Testing (UAT) of clinical data base. Execute documents such as clinical data management plans, guidelines for CRF completion, Reconciliation of Serious Adverse Events, Trial master file (TMF) plans & data audits.
• Develop data transfer agreements and specifications for data sources (Central labs, biomarkers, Electrocardiogram, CT/MRI Imaging etc.)
• Review clinical data, data listings and patient profiles for data consistency. Compile clinical data for regulatory submissions like Biologics License Application (BLA), New Drug Application (NDA) to U.S. Food and Drug Administration (FDA), European Medicines Agencies (EMA) and Pharmaceutical and Medical Device Agencies (PMDA).

Skills: CDISC, CDASH, edit check & UAT.

Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting. Send resume to Nexpro Technologies Inc, 114 Crockett Rd, King of Prussia, PA 19406.