Ferring Pharmaceuticals Inc.
Director, Clinical Data Management Solutions
Ferring Pharmaceuticals Inc., Lake Hiawatha, New Jersey, us, 07034
Key Responsibilities
Identify optimal clinical data management (CDM) solutions for capturing, integrating, and processing clinical data from different sources (e.g., eCRF, ePRO, eCOA, central laboratory).
Provide end‑to‑end CDM support by specifying CRF metadata using Trial Definition Tool, EDC functionalities, data validation/transfer specifications and CDM plans; implement data visualization application including Qlik‑Sense for centralized monitoring; conduct SAS programming, system/data transfer monitoring, system trainings, and clean file meetings.
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; conduct quality reviews against SOPs/regulatory requirements; participate in internal/external audits/inspections.
Develop and maintain relevant talents in CDM function via strategic hiring, continuous mentoring/training, performance management, and internal/offshore resource management.
Lead and participate in process improvements by staying updated on advanced CDM solutions via technical literature/professional conferences; author SOPs and/or working instructions for CDM processes and usage of home‑grown/off‑the‑shelf tools.
Experience 10 years of experience in this role or as an Associate Consultant or any other job title performing all listed duties. Salary: $155,000/year. Apply online at
https://www.ferringusa.com .
#J-18808-Ljbffr
Identify optimal clinical data management (CDM) solutions for capturing, integrating, and processing clinical data from different sources (e.g., eCRF, ePRO, eCOA, central laboratory).
Provide end‑to‑end CDM support by specifying CRF metadata using Trial Definition Tool, EDC functionalities, data validation/transfer specifications and CDM plans; implement data visualization application including Qlik‑Sense for centralized monitoring; conduct SAS programming, system/data transfer monitoring, system trainings, and clean file meetings.
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; conduct quality reviews against SOPs/regulatory requirements; participate in internal/external audits/inspections.
Develop and maintain relevant talents in CDM function via strategic hiring, continuous mentoring/training, performance management, and internal/offshore resource management.
Lead and participate in process improvements by staying updated on advanced CDM solutions via technical literature/professional conferences; author SOPs and/or working instructions for CDM processes and usage of home‑grown/off‑the‑shelf tools.
Experience 10 years of experience in this role or as an Associate Consultant or any other job title performing all listed duties. Salary: $155,000/year. Apply online at
https://www.ferringusa.com .
#J-18808-Ljbffr