Senior Clinical Trial Manager- (Sponsor-Dedicated, Remote - US)
12 days ago
Philadelphia
Senior Clinical Trial Manager- (Sponsor-Dedicated, Remote - US) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: 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 building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities Location: Remote - United States (East or Central Time preferred) Where strategy meets operational excellence. We're seeking an experienced Senior Level Clinical Trial Manager join our sponsor-dedicated team in the role of Site Monitoring Lead (SML) to 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 but must include). * Oversight-not execution-of site monitoring activities, including management and performance oversight 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, deviation management, inspection readiness, and resolution of operational challenges. * 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, partnering closely with Clinical Operations, Data Management, Safety, Regulatory, Biometrics, and external vendors. * Demonstrated ability to manage CROs and functional vendors, including monitoring, central labs, imaging, and other service providers, ensuring delivery against timelines, quality, and study objectives. * Advanced project and trial management capabilities, including ownership of study timelines, milestone delivery, operational risk identification, and resolution across competing priorities. * Excellent communication and stakeholder management skills, with the ability to lead and influence CRAs, vendors, and cross-functional teams in a global, matrixed structure. * Demonstrated Agility, Accountability, and Intrapreneurship (AAI), with a results-oriented mindset, sound judgment, and the ability to make informed decisions in a fast-moving early-phase environment. * * Opportunity to shape and optimize site monitoring strategies across diverse, high-impact clinical programs. * Work within a collaborative, science-driven culture that values innovation, agility, and excellence in delivery. * Engage directly with global teams, vendors, and regulatory stakeholders to drive success from early development through marketing authorization. * A dynamic environment that rewards leadership, critical thinking, and operational insight. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $95,000.00 - $175,700.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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