Clinical Operations Lead

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.
 

What Youll Do: 

• 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
   

Qualifications :

Education and Training Required:

• Associate degree (2-year program) or equivalent level of education required; Bachelors Degree (4 year program) in a related field preferred

Minimum Experience: 

• 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

Additional Information :

About M3: 

M3 USA is at the forefront of healthcare innovation offering digital solutions across healthcare life sciences pharmaceuticals and more. Since our inception in 2000 weve seen remarkable growth fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.

Our success is anchored in our trusted digital platforms that engage physician communities globally facilitating impactful medical education precise job placement and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.

Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.

Benefits: 

A career opportunity with M3 Wake Research offers competitive wages and benefits such as:

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

*M3 reserves the right to change this job description to meet the business needs of the organization

#LI-Remote
#LI-LB1

Remote Work :

Yes

Employment Type :

Full-time