Director of Clinical Data Management & Data Standards

Ferring Pharmaceuticals Inc.; Parsippany-Troy Hills (NJ); Sur place; USD 140 000 - 171 000; Plein temps

Résumé du poste

Ferring Pharmaceuticals Inc. is seeking a Senior CDM Lead with extensive experience in clinical data management to drive end-to-end CDM initiatives.

You will specify CRF metadata, CFD transfer specs, and implement data visualization solutions using Qlik-Sense while ensuring adherence to regulatory requirements. The role requires strong SAS programming skills and a track record in managing CDISC SDTM datasets, submission packages, and audits.

Qualifications

• 10 years of experience in CDM or related roles.
• Experience with CDISC SDTM datasets and submission packages (define.xml, aCRFs, cSDRG).
• Regulatory compliance experience and participation in audits/inspections.

Responsabilités

• Identify optimal clinical data management (CDM) solutions for capturing, integrating, and processing data from diverse sources.
• Provide end-to-end CDM support by specifying CRF metadata, EDC functionalities, data validation/transfer specs and CDM plans; implement data visualization (Qlik-Sense).
• Ensure regulatory compliance of CDM deliverables by developing data standards and submission packages; perform quality reviews against SOPs/regulatory requirements.
• Develop and mentor CDM talent through strategic hiring, training, and offshore resource management.
• Lead process improvements by staying updated on advanced CDM solutions and authoring SOPs for CDM processes.

Connaissances

CDM

SAS programming

Regulatory compliance

Data standards

Outils

Trial Definition Tool

EDC

Qlik-Sense

SAS

Pinacle21

Description du poste

Ferring Pharmaceuticals Inc. is seeking a Senior CDM Lead with extensive experience in clinical data management to drive end-to-end CDM initiatives.

You will specify CRF metadata, CFD transfer specs, and implement data visualization solutions using Qlik-Sense while ensuring adherence to regulatory requirements. The role requires strong SAS programming skills and a track record in managing CDISC SDTM datasets, submission packages, and audits.