Scientific Program Manager (Ph.D)

Job opening ID
2590

Posting title
Scientific Program Manager (Ph.D)

Roles and responsibilities
Must be a US Citizen. 
Travel required.

Columbus Technologies and Services Inc. is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Columbus offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking Scientific Program Manager to work onsite with the National Institutes of Health in Rockville, MD.

This is a long-term position which offers:
- Competitive salary
- Tremendous growth opportunity
- Opportunity to work at NIH, the world's foremost medical research center
- Learn more about what Columbus can do for you at www.columbususa.com

Job Description:
The contractor shall:
• Provide expert advice to NIAID staff on regulatory issues related to clinical trials supported by NIAID through grants and contracts.   
• Assist Program Officers at NIAID in implementation of clinical trials through coordination within NIAID and coordination of resources provided by NIAID (e.g., laboratory, pharmacy, statistics and data management, and regulatory contracts, and other resources). 
• Provide expert advice to NIAID staff on the capabilities of international laboratories associated with clinical trial sites.  Identify deficiencies and gaps in laboratory operations when requested.
• Participate in or coordinate site visits to international laboratories.  These visits frequently involve coordination with other NIAID support contractors, NIAID grantees and NIAID staff.  Prepare evaluation reports, site visit reports, and other information documents as needed.
• Make recommendations to NIAID staff regarding laboratories that would benefit from training in GLP and GCLP, performance of clinical safety assays, diagnostic assays, study eligibility assays, endpoint assays, specimen handling, storage, and shipment or laboratory data management. Provide or coordinate training for laboratory sites when requested by NIAID staff.
• Serve as a resource for individual country regulations and accreditation requirements for laboratory operations, such as shipping many types of biological samples to other in country and international laboratories or repositories.

Required Skills:
The contractor must have:
• Ph.D. with extensive knowledge of immunology, microbiology, and/or molecular biology literature relevant for TB and TB/HIV therapeutics research, with an emphasis on translational research to advance new preclinical discoveries.
• Minimum of six (6) years of experience in biology or a related field.
• Knowledge of laboratory regulatory requirements, particularly as relates to Laboratory Developed Tests (LDTs) in the areas of immunology, virology, pharmacology and TB testing, is preferred.    
• Demonstrated knowledge of a broad range of scientific and technical areas.
• Demonstrated strong managerial experience.
• Demonstrated expertise with Microsoft Office (Word, Excel, etc.).
• Excellent written and oral communication and interpersonal skills. 


Number of positions
1

Location
Rockville

State
Maryland