Program/Technical Advisor (Mid-level)

Caduceus Healthcare

Washington, DC(remote)

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Accounts Receivable, Administrative Skills, Biochemistry, Biology, Biomedical Research, Clinical Data Interchange Standards Consortium (CDISC), Contract Management, Cross-Functional, Customer Relations, Data Analysis, Data Management, Data Quality, Data Sets, Department of Health and Human Services, Establish Priorities, FDA (Food and Drug Administration), ICH Regulations, Immunology, Infectious Diseases, Maintain Compliance, Medicine, Microbiology, Microsoft Exchange Server, Molecular Biology, Pharmacy, Product Development, Quality Management, Regulations, Research & Development (R&D), Research Contracts, Technical Support, Willing to Travel, Work From Home

LOCATION

Washington, DC

POSTED

7 days ago

BARDA / Nonclinical Data Standards and Analytics Program/Technical Advisor (Mid-level) Description of Role: The Biomedical Advanced Research and Development Authority (BARDA) within the office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services (HHS) improves national preparedness for chemical, biological, radiological, and nuclear (CBRN) accidents and attacks, pandemic influenza, and emerging infectious diseases by supporting the development and acquisition of medical countermeasures (MCM) against these threats. BARDA is looking for a Nonclinical Data Standards and Analytics Program/Technical Advisor to support the Division of Nonclinical Development (DNCD), Data Operations Program. The ideal candidate is excited to develop, implement, and manage a data quality and compliance management program for contracted nonclinical research across BARDA’s programs and provide subject matter expertise in nonclinical data standards and advanced analytics to support the development and implementation of a Nonclinical Data Coordination Center (DCC) platform tool. This position focuses on implementation and governance of DCC datasets structured according to and extensive professional experience in CDISC Standard for the Exchange of Nonclinical Data (SEND), with emphasis on SEND Implementation Guide – Animal Rule (SENDIG-AR), 2019, and alignment with FDA Guidance 'Product Development Under the Animal Rule. This is a full-time, remote position within some travel (25% or less) that requires the ability to obtain Public Trust; Tier 2 clearance. Preference for DMV area, but not a requirement Required Qualifications: Advanced degree (e.g., Ph.D., M.P.H., M.S.) in biological and/or chemical sciences such as medicine, pharmacy, life science fields (e.g., immunology, molecular biology, biochemistry, microbiology, or similar) Minimum eight (8) years of relevant industry and/or relevant postdoctoral experience in regulatory data standards and analytics Direct SEND implementation experience Client-focused approach to work; Ability to prioritize workload in a hybrid/remote work environment Ability to work well with a multi-disciplinary team of professionals; Flexible attitude with respect to work assignments and new learning Preferred Qualifications: Extensive knowledge of FDA/ICH guidelines and CDISC data standards preferred Experience with

About the Company

Caduceus Healthcare

Caduceus is a Certified and Verified HUBZone, and Service Disabled Veteran Owned Small Business (SDVOSB) that provides healthcare, information technology and security, and scientific services for our clients. We are known for offering cutting-edge solutions, employing industry best practices, and providing excellent customer satisfaction. We believe that our greatest strengths are our exceptional personnel, their focus on quality, and their deep domain knowledge of the Federal marketplace.

COMPANY SIZE

100 to 499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2008

WEBSITE

https://caduceusstaffing.com

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