Amendment Implementation Specialist

BrazilRemoteFull-timemid

Implementation SpecialistCustomer Success

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Quick Summary

Overview

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for an Amendment Implementation Specialist based in Brazil.

Technical Tools

Implementation SpecialistCustomer Success

As an Amendment Implementation Specialist, you will support the successful implementation and coordination of clinical trial amendments, ensuring project deliverables meet quality standards, contractual obligations, and client expectations. You will collaborate with cross-functional teams, clients, and internal stakeholders to coordinate information flow and keep clinical research projects on track. Your responsibilities will include monitoring project progress, maintaining accurate reporting, identifying potential risks, and supporting contingency planning. You will also contribute to budget oversight and the management of financial and contractual aspects associated with clinical trial amendments. Working in a global, collaborative environment, you will help ensure efficient project execution and consistent delivery across clinical research programs. This is an opportunity to contribute to the development of clinical studies that support medical innovation and improve patient outcomes.

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

~2 min read

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.