Associate Study Start-up Specialist

Accountabilities: The Associate Study Start-up Specialist will support clinical trial activation processes by coordinating documentation, submissions, timelines, and communication with internal and external stakeholders. The role requires attention to detail, knowledge of clinical research standards, and the ability to manage multiple priorities while ensuring regulatory compliance.

Support study start-up activities, including site feasibility, site selection, activation processes, and ongoing submission activities.

Prepare and manage submission packages for Ethics Committees and Regulatory Authorities according to applicable regulations, SOPs, and guidelines.

Coordinate document collection, review, translation processes, and tracking of essential clinical trial documentation.

Assist with regulatory submissions, approvals follow-up, and delivery of required documents to sites and authorities.

Maintain accurate study start-up data and documentation within clinical trial management systems (CTMS), when applicable.

Review project timelines, support planning activities, and help ensure milestones are achieved efficiently.

Collaborate with clinical operations teams and other stakeholders to improve workflows and reduce study start-up cycle times.

Contribute to continuous improvement initiatives related to study start-up processes and operational infrastructure.

Requirements:

The ideal candidate has experience in clinical research or clinical operations, strong organizational skills, and the ability to work effectively in a regulated environment. A proactive mindset, clear communication, and familiarity with clinical trial requirements are essential for success.

Bachelor’s degree or higher in a scientific, healthcare, or related discipline preferred.

Minimum of 1 year of progressive experience in clinical research, clinical operations, biotechnology, pharmaceutical, CRO, or clinical site environments.

Knowledge of clinical trial execution processes, ICH/GCP guidelines, and relevant regulatory requirements.

Experience supporting study start-up activities, regulatory submissions, or essential document management is preferred.

Strong written and verbal communication skills in English, with professional fluency required.

Highly organized with strong attention to detail and ability to prioritize multiple tasks.

Ability to collaborate effectively with cross-functional and international teams.

Strong follow-through, problem-solving skills, and a results-oriented approach.

Intermediate proficiency with Microsoft Office tools, including Outlook, Word, Excel, PowerPoint, and Teams.

Availability for occasional travel, up to approximately 10%.

Benefits:

Remote work model based in São Paulo, Brazil.

Opportunity to work within a global clinical research environment.

Exposure to innovative healthcare and oncology-focused projects.

Professional development opportunities within clinical operations and regulatory fields.

Collaborative workplace focused on learning, excellence, and impactful healthcare solutions.

Competitive compensation package according to experience and qualifications.

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