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.