Site Activation Partner I - FSP

Jobgether; Brasil; Teletrabalho; BRL 90 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

7-month assignment

Remote work Brazil

International exposure

Resumo da oferta

Jobgether, on behalf of a partner company, seeks a Site Activation Partner I - FSP based in Brazil to drive site activation and start-up activities across the lifecycle.

You will coordinate essential documents, regulatory submissions, ethics processes, and site readiness, collaborating with investigator sites, study teams, and regulatory stakeholders.

This 7-month assignment offers remote work from Brazil with potential transition to a full-time role and exposure to international clinical trials.

Qualificações

• At least 3 years of relevant experience in clinical site management.
• Experience supporting clinical trials involving the US/Canada is preferred.
• Strong knowledge of ICH/GCP principles, FDA requirements, and global regulations.

Responsabilidades

• Lead or support site activation activities and compile Investigator Initiation Packages within timelines.
• Review site readiness and essential documents, contracts, ethics submissions, and activation requirements.
• Prepare and track regulatory/ethics documentation (IRB, FDA forms) and country-specific submissions.
• Coordinate with sites, study teams, ethics committees, and regulators to resolve issues and keep activation on track.
• Support ethics committee workflows including approvals and dissemination to sites and teams.
• Maintain inspection-ready documentation across CTMS/eTMF/eISF and related systems.
• Assist with post-activation activities, amendments, and annual ethics approvals.
• Support audits/inspections readiness and periodic file reviews.
• Communicate site status, approvals, delays, and required actions to teams.
• Identify and resolve site-level issues with cross-functional teams.
• Provide guidance on study documentation and regulatory requirements to site personnel.
• Contribute to process improvements and global project initiatives.

Conhecimentos

Site Activation

Clinical trials

Regulatory submissions

IRB/ethics

CTMS

eTMF

GCP

FDA requirements

US/Canada trials

Investigator platforms

Formação académica

Bachelor’s degree in Life Sciences

Ferramentas

CTMS

eTMF

eISF

Investigator portals

Document portals

Descrição da oferta de emprego

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Site Activation Partner I - FSP based in Brazil.

This role offers an opportunity to support clinical research studies from site start-up through study close-out, ensuring activities are completed accurately, efficiently, and in compliance with applicable requirements. You’ll work closely with investigator sites, study teams, regulatory stakeholders, and other partners to facilitate successful site activation and ongoing study operations. A key focus will be managing essential documentation, regulatory submissions, ethics processes, and site readiness activities within required timelines. You’ll also help maintain high-quality trial records and support sites throughout the study lifecycle. The position combines independent ownership with close collaboration across international clinical research teams. It is particularly suited to professionals with strong site activation experience and knowledge of US/Canada clinical trial requirements.

Accountabilities:

• Lead or support clinical trial site activation activities, coordinating essential documents and start-up requirements to compile high-quality Investigator Initiation Packages and achieve site initiation readiness within established timelines.
• Work directly with investigator sites to confirm readiness, reviewing site profiles and critical information related to essential documents, contracts, clinical supplies, payments, ethics submissions, and other activation requirements.
• Prepare, validate, submit, and track regulatory and ethics documentation, including Investigator Initiation Packages, IRB materials, FDA 1572/Attestation Forms, amendments, and other country-specific submissions and approvals.
• Coordinate with investigator sites, study teams, ethics committees, regulatory stakeholders, and supporting functions to resolve issues, manage escalations, and keep activation activities progressing according to plan.
• Support Central and Local Ethics Committee workflows, including preparation, submission, approval tracking, communication, and dissemination of relevant approvals to study teams and investigator sites.
• Maintain accurate and inspection-ready information across clinical trial systems and platforms, including site registries, CTMS, eTMF, eISF, shared investigator platforms, document exchange portals, and applicable ethics or regulatory systems.
• Support study conduct after site activation by coordinating documentation updates, protocol amendments, annual ethics approvals, regulatory revisions, and other activities required throughout the study lifecycle.
• Ensure timely filing and quality of clinical trial documentation, assist with periodic file reviews, and support investigator sites and study teams in preparing for audits and inspections.
• Maintain proactive communication with study teams and investigator sites, providing updates on site status, approvals, delays, issues, and required actions.
• Identify and resolve site-level issues within required timelines, collaborating with study teams and country colleagues on corrective and preventive actions where appropriate.
• Support site personnel through awareness sessions and guidance on study documentation, applicable regulations, Good Clinical Practice, and operational requirements.
• Contribute to process improvements and broader initiatives, with opportunities to serve as a study point of contact, subject matter expert, mentor, or representative on global projects.

Requirements:

• At least 3 years of relevant experience in clinical site management, with hands‑on experience supporting clinical trials involving the US/Canada.
• Previous experience in the pharmaceutical industry or a CRO, particularly in clinical trial site activation or study start‑up, is preferred.
• Strong knowledge of clinical trial methodologies, ICH/GCP principles, FDA requirements, and applicable global and local country regulations.
• Diploma or equivalent combination of education, training, and experience required; a Bachelor’s degree in Life Sciences or a related discipline is preferred.
• Strong understanding of clinical research and development processes and the key operational elements of clinical trials.
• Excellent verbal and written communication skills, with the ability to work effectively with investigator sites, study teams, colleagues, and external stakeholders.
• Strong technical skills and the ability to learn and independently use multiple clinical research systems and platforms, including CTMS, eTMF, eISF, document portals, and investigator platforms.
• High attention to detail and a disciplined, quality-focused approach, with a strong commitment to compliance and right-first-time execution.
• Ability to work independently while also contributing effectively within international, cross‑functional teams.
• Strong organizational and prioritization skills, with the ability to manage multiple activities, deadlines, sites, and competing priorities.
• Working knowledge of basic medical terminology, GCP requirements, and standard computer applications, including Microsoft Office.
• Fluency in English and the local language is required; additional language capabilities are an advantage.
• Willingness and ability to learn site activation requirements and processes across multiple countries or regions as business needs evolve.

Benefits:

• 7-month temporary assignment with potential transition to a full‑time role.
• Remote work opportunity based in Brazil.
• Opportunity to contribute to clinical research programs that support the development of new therapies and healthcare solutions.
• Exposure to international clinical trials and collaboration with investigator sites, study teams, regulatory stakeholders, and cross‑functional partners.
• Opportunity to develop expertise across site activation, clinical trial operations, regulatory documentation, ethics processes, and clinical research systems.
• Potential opportunities to contribute as a subject matter expert, study point of contact, mentor, or participant in global initiatives.
• Work within a structured clinical research environment emphasizing quality, compliance, collaboration, and continuous learning.

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We appreciate your interest and wish you the best!