Director, Clinical Data Management Solutions
Parsippany, NJFull-time$155K/yrSeen 1 day agoSeen in employer's feed 1 day ago
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Job overview
The Director, Clinical Data Management Solutions identifies and implements clinical data management solutions for capturing, integrating, processing, and monitoring clinical data. The role oversees regulatory-compliant CDM deliverables and submissions, develops talent through hiring and mentoring, and leads process improvements. It also involves audits, training, resource management, and authoring procedures and work instructions.
Skills & qualifications
Skills
Qualifications
Full job description
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
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Identify optimal clinical data management (CDM) solutions for capturing, integrating, and processing clinical data from different sources (e.g., eCRF, ePRO, eCOA, central laboratory);
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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;
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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;
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Develop and maintain relevant talents in CDM function via strategic hiring, continuous mentoring/training, performance management, and internal/offshore resource management;
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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
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