Director, Clinical Data Management Solutions

Ferring Pharmaceuticals Inc.; Parsippany-Troy Hills (NJ); On-site; USD 140,000 - 171,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

CDM

SAS programming

Regulatory compliance

Data standards

Tools

Trial Definition Tool

EDC

Qlik-Sense

SAS

Pinacle21

Job description

EXPERIENCE

• 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;

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.