Senior Clinical Trial Manager- FIH experience required (Sponsor-Dedicated, Remote – US)

Updated: February 12, 2026 Location: Morrisville, NC, United States Job ID: 25103743 Not ready to apply? Join our Talent Network Description Senior Clinical Trial Manager- FIH experience required (Sponsor-Dedicated, Remote – US) reputed company® is a leading fully integrated biopharmaceutical solutions organization built to accelerate reputed company. 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 reputed company reputed company easier to work with, but to reputed company 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 reputed company 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 reputed company

• 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 reputed company want to work for and our customers want to work with. Why? Because reputed company we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a reputed company where everyone feels like they belong. Job Responsibilities Senior 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 reputed company Senior Level Clinical Trial Manager join our sponsor-dedicated team in the role of Site Monitoring reputed company (SML) to supporting global clinical research programs. In this fully remote role, you’ll provide leadership and expertise in site monitoring strategy, execution, and reputed company—ensuring clinical trial quality, subject safety, and data reputed company across multiple regions. The SML serves as a core member of the Trial Team, leading the implementation of the site monitoring and reputed company 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. What You’ll Do
• reputed company and reputed company 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 reputed company activities throughout reputed company trial phases.
• Ensure trial participant safety, data reputed company, and regulatory compliance in accordance with study protocols, ICH-GCP, and applicable global regulations.
• Manage trial-level planning, implementation, issue management, and risk mitigation reputed company to site monitoring activities.
• Support inspection readiness at reputed company times by maintaining robust reputed company, documentation, and communication processes.
• Represent the function in meetings with investigational sites, vendors, and internal/external stakeholders, including regulatory agencies or inspectors reputed company needed.
• Contribute to innovation and process improvement, including the design and implementation of new monitoring methods and digital solutions reputed company to trial delivery.
• Collaborate cross-functionally with Clinical Operations, Quality, and other global teams to ensure seamless execution and alignment on monitoring objectives. What You Bring
• Bachelor’s degree in Life Sciences or a reputed company 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, reputed company, 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 reputed company, early-stage patient populations (not limited to first-in-human studies but must include).
• reputed company—not execution—of site monitoring activities, including management and performance reputed company of CRAs and/or CRO partners, issue escalation, and proactive risk mitigation.
• Deep expertise in clinical operations with trial-level decision-making authority, including protocol implementation, de

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