Clinical Operations Lead

Wake Research•Raleigh, NC

1d•Remote

About The Position

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Clinical Operations Lead at Wake Research, an M3 company. This is a remote position with up to 50% domestic-travel. 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
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

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
Supports team growth and hiring efforts as needed

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