Sr. Clinical Trial Manager, FSP

Accountabilities:

Oversee all clinical operational and quality activities for assigned clinical studies of moderate to high complexity, ensuring compliance with ICH-GCP guidelines, applicable regulatory requirements, and project-specific standards.
Take on additional leadership responsibilities when required, including regional Clinical Trial Manager leadership, Clinical Study Manager responsibilities, complex program coordination, and process improvement initiatives.
Develop and maintain clinical study tools and documentation, including Monitoring Plans, Monitoring Guidelines, and Data Quality Plans, ensuring alignment with overall project objectives.
Contribute to the development and execution of Master Action Plans and ensure the timely preparation, organization, completeness, and quality of Trial Master Files (TMF), both locally and centrally.
Participate in the development and review of Case Report Forms (CRFs), CRF guidelines, informed consent templates, and other study-specific documentation.
Collaborate with project managers to prepare and participate in client meetings, including bid defense presentations, project handover meetings, and ongoing study reviews.
Coordinate clinical teams and cross-functional stakeholders to ensure deliverables are achieved within established timelines, budgets, and quality expectations.
Lead regular team meetings, maintain effective communication across project stakeholders, and ensure appropriate resource allocation and collaboration.
Implement standardized clinical monitoring processes and provide training to ensure consistency with corporate policies, procedures, and study requirements.
Monitor study performance through clinical timelines, operational metrics, tracking tools, and management systems, identifying risks and implementing recovery plans when necessary.
Review monitoring visit reports, oversee CRF collection and query resolution, and ensure timely completion of clinical deliverables.
Maintain regular communication with clinical study sites regarding protocol requirements, patient participation, case report form completion, and other study-related matters.
Coordinate clinical study start-up activities when required, ensuring essential document quality and timely regulatory submissions.
Review and follow up on questions or requests raised by ethics committees and ensure appropriate resolution within project timelines.
Contribute to clinical activity forecasts, financial estimates, budget monitoring, and overall project financial management.
Manage clinical resources, assign and delegate responsibilities, evaluate team workloads, and identify additional staffing requirements when needed.
Conduct Accompanied Field Visits (AFVs) when required and ensure effective oversight of clinical monitoring activities.
Ensure appropriate archiving of study documentation and materials in accordance with applicable procedures and regulatory standards.
Requirements:
Bachelor's degree or equivalent academic or vocational qualification in a relevant discipline, such as Life Sciences, Nursing, Pharmacy, or a related field.
At least 8 years of relevant professional experience in clinical research, clinical trial management, or a comparable role.
Equivalent combinations of education, professional training, and directly related experience may also be considered.
Comprehensive knowledge of clinical monitoring practices, clinical trial operations, and study management requirements.
Strong understanding of international clinical research regulations and guidelines, particularly ICH-GCP and applicable FDA requirements.
Proven leadership capabilities, including experience mentoring, training, motivating, and coordinating multidisciplinary clinical teams.
Excellent planning and organizational skills, with the ability to prioritize competing demands and manage both individual and team workloads effectively.
Strong interpersonal, communication, and problem-solving skills, particularly within multicultural and matrix-based organizations.
Demonstrated ability to manage clinical studies independently, ensuring delivery within agreed timelines, budgets, and quality standards.
Solid understanding of change management principles, risk assessment, escalation procedures, and operational decision-making.
Strong financial and business acumen, including experience with budgeting, forecasting, resource planning, and financial performance monitoring.
Ability to evaluate resource utilization against project budgets and make appropriate adjustments to ensure operational efficiency.
Excellent written and verbal communication skills, including professional proficiency in English.
High attention to detail and strong documentation management capabilities.
Proficiency in Microsoft Office applications, particularly Outlook, Excel, and Word, as well as other clinical trial management systems and computerized applications.
Ability to work effectively with internal teams, external stakeholders, investigators, and clinical research sites.
Flexibility to accommodate occasional domestic and international travel when required by study responsibilities.
Benefits:
Work arrangement: Fully remote position based in Brazil.
Employment type: Full-time opportunity.
Work schedule: Standard working hours, Monday to Friday.
Global exposure: Opportunity to collaborate with international clinical research teams and multidisciplinary stakeholders.
Professional development: Exposure to complex clinical studies, advanced research processes, and opportunities to expand clinical trial leadership expertise.
Meaningful impact: Opportunity to contribute to scientific innovation and clinical research initiatives that support the development of solutions to improve global health.
Collaborative environment: Work alongside experienced professionals in a quality-driven, science-focused organization.
Career growth: Opportunities to strengthen leadership, project management, regulatory, and clinical operations expertise.