Site Activation Partner I - FSP

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.