Director, Clinical Data Management Solutions

Experience Required

10 years

Minimum Education Required

High School Diploma or Equivalent

Compensation

$155,000.00 - $155,000.00 / Yearly

Hours Per Week

40

Number Of Positions

1

Shift

First Shift (Day)

Job Description

• 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 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;
• 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;
• 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; 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.

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled

Place of Work

On-site

Requisition ID

R0018693

Job Type

Full Time