Location
Rockville MD
Job Type
Full-Time Regular

Position Title: Clinical Operations Manager, Full-Time
Contract Duration: 12-month base period with renewable option periods
Location: Rockville, Maryland
Department: Veritas Management Group/NIH SOAR

Summary

Veritas Management Group (VMG) is a leading management consulting firm offering solutions to complex challenges involving public health, technology, and military domains. We serve government and commercial sector organizations, academic institutions, and non-profit organizations, domestically and globally. We are committed to transforming public health through equitable, data-driven solutions.

VMG is seeking an experienced Clinical Operations Manager to support the National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID). This position provides comprehensive clinical operations and project management support for clinical research programs by coordinating study logistics, managing essential clinical documentation, tracking protocol activities, supporting regulatory processes, and facilitating communication among investigators, program staff, and stakeholders. The Clinical Operations Manager plays a critical role in ensuring the efficient administration of clinical studies while supporting the Division's infectious disease research mission.

Key Responsibilities

  • Coordinate clinical study and clinical trial logistics in accordance with DMID policies and standardized operating procedures.
  • Develop and implement standardized processes for organizing clinical studies and trial management activities.
  • Assist program staff with the development, collection, quality review, and maintenance of essential clinical study documents.
  • Ensure accurate entry and maintenance of clinical documentation within DMID databases.
  • Track the development and implementation of clinical monitoring plans and monitor the status of data and safety reviewers.
  • Meet regularly with program staff to provide updates on ongoing projects, priorities, and assigned activities.
  • Support special projects requiring immediate attention while ensuring timely completion of deliverables.
  • Plan, coordinate, and facilitate meetings with program staff, investigators, contractors, and other stakeholders.
  • Prepare meeting agendas, capture meeting minutes, and distribute action items and follow-up documentation.
  • Provide clinical project management support for the Enteric and Sexually Transmitted Infections Branch (ESTIB).
  • Inventory, organize, review, and maintain clinical study files and supporting documentation for low-resource clinical studies.
  • Work directly with funded investigators to ensure all required clinical documentation is submitted in accordance with DMID policies.
  • Coordinate 10-day pre-Council application reviews to ensure applications are appropriately assigned and reviewed on schedule.
  • Monitor and ensure timely completion of gender and minority enrollment coding for clinical research studies.
  • Serve as the primary point of contact, or support the designated point of contact, for research agreements including Non-Clinical Evaluation Agreements (NCEAs), Material Transfer Agreements (MTAs), and Clinical Trial Agreements (CTAs).
  • Maintain and update the Management Information System (MIS) database, including reviewing content, processing service requests, uploading study results, and coordinating with requestors.
  • Develop, maintain, and enhance SharePoint sites supporting RDB and ESTIB operations.
  • Prepare reports, status updates, correspondence, and documentation supporting clinical operations and research management activities.

Required Qualifications

  • Bachelor's degree in Business Management, Business Administration, or a related discipline (or equivalent experience).
  • Minimum of seven (7) years of progressively responsible experience supporting clinical operations, clinical research administration, or program management.
  • Demonstrated experience with clinical program management, protocol management, and budget tracking.
  • Experience coordinating clinical research documentation and regulatory records.
  • Experience supporting multidisciplinary clinical research teams.
  • Strong organizational, analytical, and project management skills.
  • Excellent written, verbal, and interpersonal communication skills.
  • Proficiency with Microsoft Office Suite and SharePoint.
  • Ability to manage multiple priorities while maintaining a high level of accuracy and attention to detail.

Preferred Qualifications

  • Experience supporting NIH, NIAID, or other federally funded clinical research programs.
  • Experience coordinating infectious disease clinical trials.
  • Knowledge of clinical trial regulations, Good Clinical Practice (GCP), and federal research requirements.
  • Experience managing research agreements, including Clinical Trial Agreements (CTAs), Material Transfer Agreements (MTAs), and Non-Clinical Evaluation Agreements (NCEAs).
  • Experience maintaining clinical research databases and SharePoint collaboration sites.
  • Experience supporting grant reviews, pre-Council activities, or research portfolio management.

Work Environment

  • Full-time position (40 hours per week).
  • Monday through Friday schedule.
  • Position is located at the National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID) in Rockville, Maryland.
  • Telework is available in accordance with government approval.
  • Professional office environment supporting clinical research administration and program operations.
  • Position requires close collaboration with investigators, program officers, research administrators, and multidisciplinary teams while supporting high-priority infectious disease clinical research programs.
  • No direct patient care responsibilities.
  • No security clearance require