FSP CTM / Sr. CTM

Job description

Accountabilities: Manage the clinical operational and quality aspects of assigned studies, ensuring compliance with ICH-GCP, applicable regulations, study protocols, and project-specific requirements. Assume Clinical Study Manager responsibilities on smaller or less complex projects when required. Develop and maintain clinical tools and documentation, including Monitoring Plans, Monitoring Guidelines, Data Quality Plans, Master Action Plans, and relevant Trial Master File sections. Contribute to the development of CRFs, CRF guidelines, informed consent templates, and other protocol-specific materials as needed. Partner with project managers to prepare and participate in client meetings, including bid defense and project hand-off meetings. Coordinate with clinical and cross-functional teams to ensure timelines, resources, communication, quality, and deliverables remain on track. Lead team meetings, implement standardized clinical monitoring processes, and support appropriate training and onboarding activities. Monitor clinical activity timelines, metrics, visit reports, CRF collection, query resolution, and overall study performance, implementing recovery actions when needed. Maintain regular communication with project leadership and provide accurate status updates on clinical progress, risks, resources, and deliverables. Communicate with study sites regarding protocol requirements, patient participation, case report forms, and other study-related matters. Support or coordinate study start-up activities, including ethics committee and regulatory submissions where applicable, and follow up on questions and documentation requirements. Ensure essential study documentation meets regulatory and quality expectations and is archived appropriately. Support clinical resource planning, assignment, delegation, and identification of additional resource requirements. Contribute to clinical activity forecasts, budgets, and financial management, ensuring work remains aligned with contractual scope and project objectives. In smaller regions, conduct or support accompanied field visits and take responsibility for applicable project financial activities. Requirements: Bachelor’s degree or equivalent combination of relevant academic, vocational, or professional qualifications. At least 5 years of relevant experience in clinical research, clinical monitoring, clinical trial management, or a comparable field. Oncology clinical trial experience is highly preferred. Strong understanding of clinical monitoring practices, processes, and requirements. Solid knowledge of ICH-GCP, FDA guidelines, and other applicable clinical research regulations. Demonstrated leadership capabilities, including mentoring, training, motivating, and integrating multidisciplinary teams. Strong planning and organizational skills, with the ability to prioritize workloads and manage multiple deadlines. Excellent interpersonal and problem-solving skills, particularly within multicultural and matrix organizations. Ability to work effectively in changing environments involving ambiguity, complexity, and evolving priorities. Strong judgment and decision-making capabilities, with a proactive and accountable approach to clinical operations. Excellent written and verbal communication skills, including professional proficiency in English. Ability to assess workloads against project budgets and adjust resources appropriately. Sound understanding of budgeting, forecasting, financial planning, and fiscal management. Strong attention to detail and commitment to clinical quality. Proficiency with standard business and clinical technology tools, including Microsoft Outlook, Excel, and Word. Willingness and ability to travel domestically and internationally when required by study activities. Benefits: Fully remote work opportunity in Brazil. Full-time position with a standard Monday–Friday schedule. Opportunity to work on global clinical research programs and contribute to meaningful healthcare outcomes. Exposure to multidisciplinary and multicultural teams in an international environment. Professional development opportunities through leadership, mentoring, and cross-functional collaboration. Opportunity to work with complex clinical studies and develop expertise in clinical trial management. Supportive environment focused on innovation, collaboration, scientific excellence, and continuous development. Potential travel opportunities associated with clinical trial and study-site activities. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a FSP CTM / Sr. CTM based in Brazil. This role offers the opportunity to lead clinical trial operations and deliver high-quality clinical outcomes within a global research environment.You will oversee clinical activities for studies ranging from low to moderate complexity, ensuring timelines, quality, costs, and contractual commitments are met.The position combines clinical leadership, cross-functional collaboration, operational planning, and stakeholder management.You will work closely with clinical teams, project managers, study sites, and other functions to keep trials progressing efficiently.The role also provides opportunities to contribute to study start-up, monitoring strategy, documentation, risk management, and process improvement.Strong judgment, organization, and communication will be essential when managing competing priorities and complex clinical situations.This is a fully remote opportunity suited to an experienced clinical professional who wants to make a meaningful impact in clinical research.