Clinical Operations Lead

Role Overview

• 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

Requirements

• Associate degree (2-year program) or equivalent level of education required; Bachelor’s Degree (4 year program) in a related field preferred
• 5 years or more of clinical research experience within a Clinical Research Site/Network or Contract Research Organization (CRO)
• Experience as a Clinical Research Coordinator and/or Clinical Research Associate preferred
• Understanding of clinical research process and pharmaceutical development lifecycle
• Experience with Salesforce, RealTime CTMS, eSource and eDocs or other CTMS and eRegulatory platform preferred
• 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

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