Clinical Research Data Manager - NIH

Summary

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. The National Institutes of Health is seeking a Data Manager supporting clinical research. This is a long-term, full-time, contract position based in Bethesda, MD. This position offers a competitive benefits package.

This is a long-term contract position which offers:

- Competitive compensation and comprehensive benefit package

- Optional health, vision, and dental plans

- Paid leave, paid federal holidays, and 401K plan.

- Access to NIH’s unparalleled resources and niche scientific initiatives

PRIMARY RESPONSIBILITIES:

• Assist with Clinical Data Management (CDM) activities with clinical trial monitors
• Maintain study databases and conducts basic analysis.
• Design and develop databases to clinical trial data specifications, eCRF vs paper CRF, user requirements, edit rules, query logic, and data validations.
• Data management resource for clinical team for preparation of data collection for clinical study reports, regulatory submissions, and assist with other clinical data submissions.
• Ensure clinical data within electronic data capture (EDC) is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and as a final locked database.
• Assist researchers collect, distribute and file regulatory documents.
• Assist researchers prepare submissions to regulatory bodies in support of clinical trials.
• Assist with Clinical Data Management (CDM) activities with clinical trial monitors 5 Provides technical support to researchers and the clinic.
• Generate Data and Safety Monitoring Board (DSMB) reports, Safety Review and Communication Plan (SRCP) reports, and other custom data reports as requested by the PI.
• Serve as data management resource for clinical team for preparation of data collection for clinical study reports, regulatory submissions, and assist with other clinical data submissions.

REQUIREMENTS:

• Minimum bachelor’s degree in a Science related field with at least six (6) years of data management experience with CRF and DFdiscover databases.

Job Description

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. The National Institutes of Health is seeking a Data Manager supporting clinical research. This is a long-term, full-time, contract position based in Bethesda, MD. This position offers a competitive benefits package.

This is a long-term contract position which offers:

- Competitive compensation and comprehensive benefit package

- Optional health, vision, and dental plans

- Paid leave, paid federal holidays, and 401K plan.

- Access to NIH’s unparalleled resources and niche scientific initiatives

PRIMARY RESPONSIBILITIES:

• Assist with Clinical Data Management (CDM) activities with clinical trial monitors
• Maintain study databases and conducts basic analysis.
• Design and develop databases to clinical trial data specifications, eCRF vs paper CRF, user requirements, edit rules, query logic, and data validations.
• Data management resource for clinical team for preparation of data collection for clinical study reports, regulatory submissions, and assist with other clinical data submissions.
• Ensure clinical data within electronic data capture (EDC) is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and as a final locked database.
• Assist researchers collect, distribute and file regulatory documents.
• Assist researchers prepare submissions to regulatory bodies in support of clinical trials.
• Assist with Clinical Data Management (CDM) activities with clinical trial monitors 5 Provides technical support to researchers and the clinic.
• Generate Data and Safety Monitoring Board (DSMB) reports, Safety Review and Communication Plan (SRCP) reports, and other custom data reports as requested by the PI.
• Serve as data management resource for clinical team for preparation of data collection for clinical study reports, regulatory submissions, and assist with other clinical data submissions.

REQUIREMENTS:

• Minimum bachelor’s degree in a Science related field with at least six (6) years of data management experience with CRF and DFdiscover databases.