Amendment Implementation Specialist

• Coordinate amendment implementation activities across assigned clinical research projects, collaborating with cross-functional teams to ensure timely and accurate delivery.

• Facilitate the flow of information between internal departments, clients, and functional teams involved in clinical trial amendments.

• Contribute to the development and implementation of project plans, operational guidelines, and processes that support effective amendment delivery.

• Monitor project status, track milestones, and assess progress to ensure deliverables meet established timelines, quality standards, and contractual requirements.

• Prepare and maintain project metrics, status reports, and progress updates for senior team members and management.

• Identify potential project risks, assess their impact on contractual deliverables, and develop appropriate mitigation strategies and contingency plans.

• Collaborate with senior team members to support the financial and contractual management of clinical studies, including amendment-related activities.

• Help establish and maintain controls to ensure project resources, expenses, and operational activities remain aligned with approved budgets.

• Coordinate cross-functional stakeholders to address implementation challenges, resolve issues, and maintain project momentum.

• Apply clinical development guidelines, relevant directives, and established procedures to support compliant and consistent project execution.

• Maintain accurate project documentation and communicate emerging issues, risks, and progress updates to relevant stakeholders.

• Support continuous improvement in project coordination, reporting practices, and amendment implementation workflows.

Requirements:

• A bachelor's degree or equivalent qualification, supported by relevant academic or vocational training.

• At least 2 years of relevant professional experience in project coordination, clinical research operations, site activation, amendment implementation, or a related field.

• Equivalent combinations of education, training, and directly relevant professional experience may also be considered.

• Strong organizational and multitasking skills, with the ability to manage multiple deliverables, prioritize tasks, and meet project deadlines.

• Demonstrated understanding of cross-functional project management principles and the ability to collaborate effectively with teams across different functions.

• Strong attention to detail and the ability to maintain accurate documentation, reporting, and project records.

• Ability to identify risks related to project execution and contractual deliverables, evaluate potential impacts, and recommend practical solutions.

• Basic understanding of clinical research and development, including clinical trial phases, medical and therapeutic areas, and relevant medical terminology.

• Familiarity with clinical development guidelines, applicable directives, and procedures governing clinical research activities.

• Strong communication and coordination skills, with the ability to liaise effectively with internal stakeholders, clients, and cross-functional project teams.

• Ability to work effectively in a matrix environment, adapt to changing priorities, and coordinate activities across diverse teams.

• Cross-cultural awareness and the ability to collaborate professionally with colleagues and stakeholders from different backgrounds.

• A proactive, detail-oriented approach to problem-solving, risk management, and project delivery.

Benefits:

• Fully remote work: Work remotely from Brazil, with additional eligible locations across Latin America.

• Full-time employment: Follow a standard Monday-to-Friday work schedule.

• Global collaboration: Work with cross-functional teams and clients in an international clinical research environment.

• Meaningful contribution: Support clinical trial amendments that help advance medical research and the development of new therapies.

• Professional development: Build experience in clinical research operations, project management, risk assessment, and contractual deliverables.

• Cross-functional exposure: Develop collaboration and coordination skills by working with diverse teams and stakeholders.

• Career growth opportunities: Strengthen your expertise in clinical project delivery and clinical development processes.

• Purpose-driven work environment: Contribute to projects focused on advancing scientific innovation and improving health outcomes.