FSP CTM / Sr. CTM

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.