Senior Trial Manager - FS

Accountabilities: Lead and oversee the planning, execution, and completion of clinical trials, ensuring compliance with applicable regulations, guidelines, and ICH/GCP standards. Coordinate and manage clinical trial operations teams, ensuring effective collaboration, milestone achievement, and successful project delivery. Oversee the development, review, and maintenance of essential clinical trial documentation, including Case Report Forms (CRFs), source documents, templates, and study plans. Contribute to protocol and study design reviews, informed consent documentation, and provide operational guidance to Clinical Research Associates (CRAs) and investigative sites. Develop and maintain study-specific Clinical Monitoring Plans (CMPs), incorporating clear communication, escalation procedures, and appropriate follow-up actions. Lead clinical operations activities related to the evaluation, selection, and management of investigative sites and external vendors, including central laboratories and interactive voice response systems (IVRS). Drive successful site activation while ensuring clinical trials remain aligned with established timelines, quality expectations, scope, and budgets. Manage and monitor clinical monitoring teams, ensuring high-quality deliverables and timely execution of study activities. Review clinical data reports and monitoring visit documentation to optimize monitoring activities and maintain quality standards. Build strong relationships with sponsors and stakeholders, proactively addressing operational challenges and ensuring a positive customer experience. Requirements Bachelor's degree or international equivalent from an accredited institution, preferably in clinical, biological, scientific, or healthcare-related disciplines, or an equivalent combination of education, training, and experience. At least 10 years of clinical research experience, including a minimum of 7 years overseeing global clinical studies and managing CRO activities on behalf of sponsors. Demonstrated therapeutic experience in rare dermatology, immunology, inflammation, and/or autoimmune disease areas. Strong knowledge of clinical trial management, global study oversight, regulatory requirements, and ICH/GCP guidelines. Proven ability to manage complex clinical research projects, coordinate multidisciplinary teams, and deliver milestones within established timelines and budgets. Experience overseeing clinical monitoring activities, investigative site selection and activation, vendor management, and study documentation. Excellent written and verbal communication skills in English, with the ability to engage effectively with sponsors, investigative sites, and internal stakeholders. Strong analytical, organizational, and problem-solving abilities, with excellent attention to detail. Ability to work independently, manage multiple projects simultaneously, and adapt to changing priorities in a fast-paced environment. Demonstrated commitment to customer satisfaction, accountability, quality, and timely delivery. Candidates located in the Eastern Time Zone are preferred. Benefits Competitive annual base salary: Starting at $150,000 USD, with final compensation determined by qualifications, experience, skills, and competencies. Comprehensive benefits package, potentially including health insurance and retirement plans. Paid time off. Fully remote working arrangement within the United States. Opportunities for continuous learning, professional development, and career growth. Access to innovative technologies and resources supporting clinical research excellence. Collaborative and inclusive working environment that encourages creativity, flexibility, and teamwork. Opportunity to contribute to clinical research programs that advance medical innovation and improve patients' lives.