Study Start Up Specialist

Sobre a oportunidade

We are seeking a detail-oriented and proactive professional to support the successful initiation of clinical trials.

Local

São Paulo - SP

Remoto

Responsabilidades

Coordinate day-to-day study start-up activities, ensuring deliverables are completed according to established objectives, timelines, and applicable Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and regulatory requirements.

Oversee site-level start-up activities, from initial site identification through activation, under the guidance of the Global Study Start-Up Manager.

Coordinate the collection of confidentiality disclosure agreements (CDAs), site questionnaires, and essential documentation required for site activation.

Manage informed consent form (ICF) negotiations, institutional review board (IRB) or ethics committee (EC) submissions, investigational medicinal product (IMP) release requirements, and other site activation deliverables.

Support the implementation of regional study start-up strategies and contribute to the consistent application of global processes, standards, and tools.

Prepare study-level essential document templates and assist with the preparation of regulatory submission materials.

Prepare and submit IMP release packages, ensuring all required documentation is accurate and complete.

Monitor and forecast site activation timelines, proactively identify potential delays or operational issues, and escalate concerns to the appropriate stakeholders.

Maintain accurate and up-to-date study information, project status reports, and financial data, where applicable, in relevant tracking systems and clinical platforms.

Build effective working relationships with internal teams, study stakeholders, site personnel, and contract staff to support successful trial execution.

Ensure adherence to applicable regulations, clinical trial guidelines, internal procedures, and quality standards throughout assigned activities.

Requisitos

Bachelor's degree in a relevant field, or an associate degree combined with at least two years of experience in healthcare or directly related clinical trial activities.

Practical knowledge of clinical trial conduct and a general understanding of drug development processes.

Familiarity with ICH/GCP guidelines and applicable regulatory requirements for clinical research.

Proven project management skills, including the ability to coordinate multiple activities, monitor timelines, and manage competing priorities.

Strong administrative and organizational abilities, with excellent attention to detail and a commitment to accurate documentation.

Excellent written and verbal communication skills, with the ability to collaborate effectively with international teams and external stakeholders.

Computer proficiency and the ability to work confidently with clinical systems, tracking tools, and project management platforms.

Advanced or fluent English proficiency is required.

Ability to work independently, identify potential risks, resolve routine issues, and escalate complex matters appropriately.

Willingness to travel occasionally, with an estimated travel requirement of 0–5%.

Benefícios

Remote work arrangement.

Full-time employment.

Opportunity to contribute to clinical research and the development of therapies that may improve patient outcomes.

Exposure to international clinical trial operations and collaboration with cross-functional, global teams.

Opportunities to develop expertise in study start-up processes, regulatory compliance, and clinical project coordination.

Carga horária

Full-time

Tipo de contrato

Permanent

Processo seletivo

AI-powered matching process

Sobre a empresa

Our partner is looking for a Study Start Up Specialist based in Brazil.

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.

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