Clinical Operations Manager - Guidehouse
Overview
We seek a Clinical Operations Manager to lead operational and administrative support for NIAID's Division of Microbiology and Infectious Diseases. This full-time onsite role in Rockville MD requires developing standardized procedures with RDB and ESTIB staff while ensuring compliance with DMID protocols. The ideal candidate will drive efficiency across clinical study logistics and deliver measurable outcomes within the first 90 days.
What You'll Do11
- 1Design and implement standardized procedures for clinical study organization aligned with DMID guidelines
- 2Develop, collect, and quality review essential clinical study documents for DMID database entry
- 3Track monitoring plans and data safety reviewer statuses to ensure regulatory adherence
- 4Coordinate with program staff to provide project updates and manage new assignments
- 5Prepare meeting minutes and take notes during stakeholder meetings
- 6Assist with clinical project management for ESTIB initiatives
- 7Inventory and organize low-resource tier clinical study documentation
- 8Ensure gender and minority coding compliance for clinical research projects
- 9Serve as primary contact for agreements including NCEAs MTAs and CTAs
- 10Maintain Medical Information System database with content reviews and request processing
- 11Create and manage RDB and ESTIB SharePoint sites
Requirements9
- 1Bachelor’s degree in Business Management Administration or related field with 2+ years clinical support experience
- 2Proven ability to obtain Federal or DoD public trust clearance
- 3Expertise with SharePoint administration and collaboration site management
- 4Strong proficiency in Microsoft Office and budget tracking systems
- 5Experience with DMID clinical research processes and agreement administration
- 6Ability to work in a public trust sensitive environment
- 7Excellent organizational and document management skills
- 8Experience with cloud-based collaboration platforms
- 9Commitment to diversity and inclusion initiatives
Salary Insight
$65 - $108k per year
Location
Required Skills
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