Site Activation Partner I

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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 through Investigator Initiation Package compilation and site initiation approval • Prepare, validate, and submit regulatory documents and support internal regulatory approval • Coordinate supporting roles, ethics committee submissions, investigator site workflows, and study approval activities • Manage clinical documentation, reports, and Shared Investigator Platform activities • Coordinate study-conduct documentation and updates, including protocol amendments, FDA 1572/Attestation revisions, and ethics committee approvals • Maintain IRB/Ethics Committee activities and file documents to the Trial Master File • Perform periodic quality reviews of study files for accuracy and completeness • Update clinical trial systems tracking site compliance and performance • Support investigator sites and study teams with audit and inspection responses • Maintain communication with study teams, investigator sites, clients, and stakeholders • Provide country- and site-level updates on site status, issues, delays, and approvals • Support site personnel awareness sessions and ongoing compliance with study documentation, applicable laws, GCP, and client standards • 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 initiatives as assigned • Support mentoring of new hires on processes and systems • Complete required training, timesheets, expense reports, and CV updates • Comply with Parexel processes, ICH-GCPs, and other applicable requirements

🎯 Requirements

• Knowledge of clinical research and development processes and key operational elements of clinical trials • Ability to understand process details and quality expectations • Compliance with applicable company, regulatory, and country requirements • Strong 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 • Knowledge of Good Clinical Practice (GCP) requirements • Proficient in computer operations and able to learn and independently use multiple systems • Experience with Microsoft Suite, Clinical Trial Management Systems (CTMS), Electronic Trial Master File, Electronic Investigator Site File, document exchange portals, Shared Investigator Platform, and ethics/governing-body portals as needed • Flexibility to work outside standard hours in a global environment when applicable • Able to travel as needed, including possible international travel • Experience in pharmaceutical industry or CRO 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; multilingual 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 • Life sciences education preferred • Minimum 2 years of relevant experience in clinical site management