Site Activation Partner I

🔥 13 minutes ago

🌐 Brazil, Argentina, +1 more countries – Remote

🇧🇷 Brazil – Remote 🇦🇷 Argentina – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🪙 Affiliate Manager

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead or support operational activities from study start-up through close-out for assigned studies and investigator sites • Initiate and coordinate activities and essential document management for Investigator Initiation Packages and site initiation approval • Register and maintain investigator sites and client stakeholders in required registries and systems • Interact with investigator sites to confirm readiness for start-up and review site profiles, essential documents, contracts, clinical supplies, payments, and IRB status • Resolve and escalate site issues and concerns • Prepare, validate, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms • Coordinate supporting roles and activities for timely site activation • Support central and local IRB submissions, ethics committee communications, approvals, and workflows • Assist with non-clinical trial supplies, tracking, clinical documentation, filing, and archiving • Support eISF readiness and manage site and monitor access before Site Initiation Visits • Coordinate document translation with preferred vendors • Manage post-activation documents and updates throughout the study lifecycle, including protocol amendments and ethics approvals • Maintain IRB/Ethics Committee activities and file documents to the Trial Master File • Update clinical trial systems tracking site compliance and performance • Support site audits and inspections • Maintain communication with study teams and investigator sites and provide country/site updates • Disseminate ethics and local site approvals to study teams and stakeholders • Conduct awareness sessions on client requirements and documentation compliance as needed • Identify and resolve investigator site issues and coordinate corrective and preventative actions • Complete assigned training and adhere to Parexel and client SOPs and processes • Potentially serve as study point of contact, subject matter expert, global initiative representative, or mentor

🎯 Requirements

• School diploma/certificate with equivalent combination of education, training and experience required; Bachelor of Science, Bachelor of Arts or Bachelor’s in Life Sciences preferred • Minimum 3 years’ relevant experience in clinical site management, working with US/Canada • Experience in pharmaceutical industry or CRO in study site activation preferred • Knowledge of clinical trial methodologies, ICH/GCP, FDA, and global and local country regulations • Fluent in the local language and English • Effective verbal and written communication skills • Good technical skills and ability to learn and use multiple systems • Knowledge of clinical research and development processes and key operational elements of a clinical trial • Understanding of quality expectations and right-first-time principles • Compliance with company, regulatory, and country requirements • Attention to detail and disciplined approach • Ability to work independently and as a team member • Ability to organize tasks, time, and priorities and multitask • Basic medical terminology knowledge, GCP requirements, and proficient computer operations • Ability to use and learn Microsoft Suite, CTMS, electronic Trial Master File, electronic Investigator Site File, document exchange portals, Shared Investigator Platform, and ethics/national networks/governing body portals

🏖️ Benefits

• Training assigned by Client and/or EP, including general training, SOP, system and process-related training • Mentoring opportunities for new hires on processes/systems • Multilanguage capability preferred