Director, Clinical Data Management Solutions

1. Identify optimal clinical data management (CDM) solutions for capturing, integrating, and processing clinical data from different sources (e.g., eCRF, ePRO, eCOA, central laboratory);

2. Provide end to end CDM support by specifying CRF metadata using Trial Definition Tool, EDC functionalities, data validation/transfer specs and CDM plans; by implementing data visualization application including Qlik-Sense for centralized monitoring; by conducting SAS programming, system/data transfer monitoring, system trainings, and clean file meetings;

3. Ensure regulatory compliance of CDM deliverables by developing data standards, CDISC SDTM datasets and submission packages (define.xml, aCRFs, cSDRG) using SAS, home-grown tools, Pinacle21 and MS products under SAS LSAF; by conducting quality review against SOPs/regulatory requirements; by participating in internal/external audits/ inspections;

4. Develop and maintain relevant talents in CDM function via strategic hiring, continuous mentoring/training, performance management, and internal/offshore resource management;

5. Lead and participate in process improvements by staying updated on advanced CDM solutions via technical literature/professional conferences; by authoring SOPs and/or working instructions for CDM processes and usage of home-grown/off-the-shelf tools

EXPERIENCE: 10 years of experience in job offered or 10 years of experience as a Associate Consultant or any other job title performing all listed job duties. Salary: $155,000/year. Apply online at https://www.ferringusa.com.