Clinical Operations Lead

M3USA • Raleigh, NC

2d • Remote

About The Position

The Clinical Operations Lead is responsible for driving the successful execution of clinical trials across multiple sites and priority programs. This role ensures studies meet enrollment targets, quality standards, and sponsor/CRO expectations throughout the study lifecycle. The Clinical Operations Lead serves as a central point of coordination between sites, sponsors, CROs, and internal teams, proactively identifying risks, removing barriers, and maintaining alignment across stakeholders. This individual plays a hands-on leadership role, in collaboration with the Site and Regional Director, in optimizing site performance, supporting operational excellence, and ensuring consistent, high-quality study execution across the network. This role requires up to 50% travel.

Requirements

• Associate degree (2-year program) or equivalent level of education required
• 5 years or more of clinical research experience within a Clinical Research Site/Network or Contract Research Organization (CRO)
• Understanding of clinical research process and pharmaceutical development lifecycle
• Mastery skills in Microsoft Word, Excel, and/or other data management tools
• Understanding of clinical and site logistics, as well as study start-up and site activation
• Strong understanding of multi-site clinical trial operations, including enrollment strategies and site performance management
• Excellent written and verbal communication skills, with the ability to engage effectively with sites, sponsors, and CROs
• Proven ability to manage multiple priorities and drive results in a fast-paced environment
• Strong problem-solving skills with a proactive, solution-oriented mindset
• High attention to detail with a focus on quality and compliance
• Ability to influence and lead cross-functional and multi-disciplinary teams without direct authority
• Strong organizational and time management skills
• Demonstrated ability to identify inefficiencies and implement process improvements
• Supports team growth and hiring efforts as needed

Nice To Haves

• Bachelor’s Degree (4 year program) in a related field preferred
• Experience as a Clinical Research Coordinator and/or Clinical Research Associate preferred
• Experience with Salesforce, RealTime CTMS, eSource and eDocs or other CTMS and eRegulatory platform preferred

Responsibilities

• Serve as the primary operational lead for assigned studies, with accountability for enrollment performance, study quality, and overall execution across multiple sites
• Partner with sponsors and CROs as a key point of contact, ensuring clear communication, alignment on expectations, and proactive management of study needs and concerns
• Work directly with site teams to monitor enrollment progress, identify barriers to recruitment, and implement targeted action plans to improve performance
• Proactively identify operational risks, including enrollment challenges and protocol-related issues; develop and execute mitigation strategies to keep studies on track
• Drive accountability across sites by tracking and managing key performance indications (KPIs), including enrollment, screen failure rates, data quality, and timelines
• Lead and facilitate study-related meetings with internal teams, sites, and sponsors/CROs, including kick-off meetings, enrollment reviews, and ongoing operational calls
• Ensure timely and effective communication across all stakeholders, providing clear updates on study status, risks, and performance
• Support study start-up, amendments, and ongoing trial execution by coordinating across functional teams to ensure efficient and compliant processes
• Maintain accurate and up-to-date tracking of study timelines, milestones, and performance metrics within internal and external systems
• Collaborate with Clinical Operations leadership to identify process improvement opportunities and implement solutions to enhance efficiency, quality, and site performance
• Provide hands-on support to sites as needed, including onsite engagement, to address operational challenges and improve execution
• Support the rollout and adoption of new processes, tools, and technologies that enhance clinical trial delivery

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree