Site Activation Partner I

🔥 0 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🪙 Affiliate Manager

🚫👨‍🎓 No degree required

👻 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

• Initiate and coordinate clinical trial site activation activities and essential document management • Compile high-quality Investigator Initiation Packages leading to site initiation approval • Resolve or escalate site issues and coordinate supporting roles to ensure timely site activation • Prepare, validate, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms • Support Central Investigator Review Board packages and submissions according to country requirements • Coordinate communications, documentation, and responses between clients and ethics committees • Support investigator sites with local IRB workflows from preparation and submission through approval • Prepare, handle, and distribute clinical documentation and reports according to scope and SOPs • Support Shared Investigator Platform activities aligned with client strategy • Coordinate essential documents and updates throughout the study lifecycle, including protocol amendments, FDA 1572/Attestation revisions, and ethics committee annual approvals • Maintain IRB/Ethics Committee activities • File documents to the Trial Master File and assist with periodic quality reviews • Update and maintain clinical trial systems tracking site compliance and performance • Support investigator sites and study teams with audit and inspection responses • Maintain communication with study teams and investigator sites and provide country- and site-level updates • Establish tools for efficient updates on site status, issues, delays, and approvals • Disseminate ethics approvals and communicate local site approvals to study teams and stakeholders • Conduct awareness sessions with site personnel on client requirements and documentation compliance as needed • Identify and resolve investigator site issues and coordinate corrective and preventative actions • Serve as a Site Activation Partner point of contact, subject matter expert, or representative on global initiatives as assigned • Support mentoring of new hires on processes and systems • Complete required training, timesheets, expense reports, and CV updates • Maintain knowledge of and comply with Parexel processes, ICH-GCP, and applicable requirements

🎯 Requirements

• 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 applicable 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 and GCP requirements • Proficiency in computer operations • Ability to use and learn systems independently • Experience with Microsoft Suite • Experience with Clinical Trial Management Systems (CTMS) • Experience with electronic Trial Master File (TMF) • Experience with electronic Investigator Site File systems, e.g. Florence • Experience with document exchange portals • Experience with Shared Investigator Platform • Experience with ethics, national networks, and governing bodies' portals and platforms as needed • Flexibility to work off-hours in a global environment when applicable • Ability to travel as needed, including possible international travel • Experience working in the pharmaceutical industry or CRO in study site activation preferred • Knowledge of clinical trial methodologies, ICH/GCP, FDA, and global and local country regulations • Fluency in the local language and English required • Multilanguage capability preferred • Effective verbal and written communication skills • Good technical skills and ability to learn and use multiple systems • School diploma or certificate with equivalent combination of education, training, and experience, or Bachelor of Science/Bachelor of Arts or equivalent • Minimum 2 years of relevant experience in clinical site management

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