Clinical Operations Lead
Remote · United States or US
Job Summary
Clinical Operations Lead responsible for driving the successful execution of clinical trials across multiple sites, ensuring enrollment targets, quality standards, and sponsor/CRO expectations throughout the study lifecycle. Serves as a central point of coordination between sites, sponsors, CROs, and internal teams; identifies risks, removes barriers, and maintains alignment. Leads operational optimization with Site and Regional Director, facilitates study-related meetings, tracks KPIs (enrollment, screen failure rates, data quality, timelines), supports start-up and amendments, coordinates across functional teams, and drives process improvements and adoption of new tools. This remote role requires up to 50% travel and requires an associate degree (required) with 5+ years of clinical research experience; bachelor’s degree preferred; proficiency with CTMS/eSource/eDocs and strong communication and leadership skills.
Required Qualifications
- 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
- Knowledge, Skill, Ability: Understanding of clinical research process and pharmaceutical development lifecycle
- Experience with Salesforce, RealTime CTMS, eSource and eDocs or other CTMS and eRegulatory platform preferred
- Excellent oral and communication skills
- 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
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