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Director, Clinical Data Management Solutions
Parsippany, NJ
Job Description
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;
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
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;
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
Special Notes/Instructions
Apply online at https://www.ferringusa.com.
Job Summary
Company
Employment Term and Type
Regular, Full Time
Salary and Benefits
155000.00
Required Experience
10 years
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