Senior Clinical Operations SME

LMI Consulting, LLC; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Operations Subject Matter Expert to support critical public health initiatives. This role involves overseeing clinical trial operations, managing project timelines, and ensuring regulatory compliance in a dynamic environment. Ideal candidates will have extensive experience in clinical trials, particularly in leadership roles, and a strong understanding of innovative clinical study designs. Join a forward-thinking consultancy dedicated to transforming government operations and making a significant impact on public health. If you are passionate about advancing clinical research and thrive in a collaborative setting, this opportunity is perfect for you.

Qualifications

• 10+ years of experience in clinical trial operations, including phase II/III trials.
• Strong understanding of CRO and DCT landscape.

Responsibilities

• Support BARDA as a subject matter expert in various threats.
• Oversee contractors and manage timelines and budgets.
• Ensure compliance with regulatory processes and develop risk strategies.

Skills

Clinical Trial Operations

Project Management

Regulatory Compliance

Risk Assessment

Clinical Research

Quality Control

Education

Advanced degree in medicine, nursing, pharmacy, or biotechnology

Job description

Senior Clinical Operations SME

Job Locations: US-Remote

Job ID: 2025-12355

Category: Engineering

Overview

LMI is seeking a Senior Clinical Operations SME to support the Biomedical Advanced Research and Development Authority (BARDA). This position can likely be performed remotely. It requires the ability to obtain a public trust clearance. You must be a U.S. citizen.

BARDA supports the development of vaccines, therapeutics, diagnostics, and innovative technologies for public health emergencies. Candidates with experience in medicinal chemistry, preclinical development, advanced clinical development, analytical testing, quality control, clinical/regulatory policy, manufacturing, process development, device development, microbiology, virology, or immunology are desired.

LMI is a consultancy dedicated to powering a future-ready government with expertise in digital solutions, logistics, and management advisory. Founded in 1961, LMI continues to enable growth, transformation, and mission success for federal agencies. We are recognized as a 2024 #BestPlacestoWork.

Responsibilities

• Support BARDA Program Office(s) as a subject matter expert in Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats, including diagnostics, medical devices, vaccines, and therapeutics.
• Serve as an internal project manager/clinical team leader overseeing contractors and vendors.
• Manage timelines, budgets, and key deliverables.
• Develop risk assessment and mitigation strategies.
• Ensure compliance with regulatory processes, including co-authoring and reviewing FDA submissions.
• Author, review, and develop RTORs and evaluate CRO proposals.
• Provide independent cost, resource, and timeline estimates.
• Review and develop work products related to clinical studies and programs within BARDA contracts.
• Oversee overall clinical operations.
• Review study-specific documents, including invoices.

Qualifications

• Advanced degree in medicine, nursing, pharmacy, biotechnology, or related field with relevant experience.
• Minimum of 10 years of clinical trial operations experience, including in registrational phase II/III trials and leadership roles.
• Experience in clinical research organizations, pharma, academia, or government.
• Expertise in diverse clinical study designs, including pragmatic and RWE studies, and decentralized approaches.
• Knowledge of clinical trial innovation and integration of new processes and technologies.
• Strong understanding of CRO and DCT landscape.
• Knowledge of quality systems, data management, laboratory facilities, etc.
• Preferred: Experience with non-traditional clinical sites and understanding of both technical and business aspects of clinical trials.
• Ability to obtain a public trust clearance; U.S. citizenship required.

LMI is an Equal Opportunity Employer committed to diversity and inclusion. For assistance, contact [e-mail].