Site Monitoring Lead; Sponsor-Dedicated, Remote

Overview

Site Monitoring Lead (Sponsor-Dedicated, Remote - US)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we create a place where everyone feels like they belong.

Site Monitoring Lead / Clinical Trial Manager (Sponsor-Dedicated, Remote - US)

Location: Remote - United States (East or Central Time preferred)

Where strategy meets operational excellence.

We re seeking an experienced Site Monitoring Lead (SML) to join our sponsor-dedicated team supporting global clinical research programs. In this fully remote role, you ll provide leadership and expertise in site monitoring strategy, execution, and oversight, ensuring clinical trial quality, subject safety, and data integrity across multiple regions.

The SML serves as a core member of the Trial Team, leading the implementation of the site monitoring and oversight approach as part of overall trial quality management. This role is critical to delivering clinical programs on time and to the highest compliance standards, in alignment with ICH-GCP, regulatory expectations, and sponsor requirements.

• Lead and oversee site monitoring activities across assigned global clinical trials, ensuring effective implementation of trial-specific monitoring strategies.
• Consult and provide expertise to Trial Teams on monitoring methodologies, risk-based approaches, and oversight activities throughout all trial phases.
• Ensure trial participant safety, data integrity, and regulatory compliance in accordance with study protocols, ICH-GCP, and applicable global regulations.
• Manage trial-level planning, implementation, issue management, and risk mitigation related to site monitoring activities.
• Support inspection readiness at all times by maintaining robust oversight, documentation, and communication processes.
• Represent the function in meetings with investigational sites, vendors, and internal/external stakeholders, including regulatory agencies or inspectors when needed.
• Contribute to innovation and process improvement including the design and implementation of new monitoring methods and digital solutions related to trial delivery.
• Collaborate cross-functionally with Clinical Operations, Quality, and other global teams to ensure seamless execution and alignment on monitoring objectives.

• Bachelor s degree in Life Sciences or a related discipline; advanced degree preferred.
• Demonstrated experience as a Clinical Trial Manager (or equivalent trial-level role) with accountability for end-to-end study execution, including planning, conduct, oversight, and closeout of clinical trials. This role requires ownership of the trial at the program level and is not a site-monitoring or CRA position.
• Proven leadership of early-phase (Phase I and IIa) clinical trials
  , including operational strategy, risk management, and execution for complex, early-stage patient populations (not limited to first-in-human studies).
• Oversight-not execution-of site monitoring activities
  , including management and performance oversight of CRAs and/or CRO partners, issue escalation, and proactive risk mitigation.
• We ll remove non-allowed tags
• Deep expertise in clinical operations with trial-level decision-making authority
• Strong working knowledge of ICH-GCP, Good Documentation Practice, and global regulatory requirements, with the ability to apply these principles at the study oversight level across FDA, EMA, and PMDA-regulated trials.
• Experience leading global, multi-regional trials within a matrixed, cross-functional environment,…