Site Activation Partner – FSP

🔥 5 minutes ago

🇫🇷 France – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🪙 Affiliate Manager

👻 Ghost score 10%

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Logo of Parexel

Parexel

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 and coordinate site activation activities and essential document management for timely site initiation and study start-up • Work with investigator sites to assess readiness, review site information, and complete Investigator Initiation Package requirements • Prepare, validate, and submit regulatory documentation, including Investigator Initiation Packages, IRB approvals, and FDA 1572 or Attestation Forms • Manage investigator site registration and maintenance in client systems, registries, and clinical trial platforms • Collaborate with study teams and supporting functions to achieve site activation and operational milestones • Support ethics committee and IRB submissions, communications, approvals, and ongoing maintenance • Coordinate document translation activities with approved vendors • Manage essential document collection, maintenance, filing, archiving, and trial master file contributions • Maintain clinical trial systems and tracking tools for site compliance, documentation status, and study performance • Support audit and inspection preparation and responses • Identify, resolve, and escalate site-related issues while supporting corrective and preventive actions • Contribute to process improvement, system expertise, knowledge sharing, and mentoring activities

🎯 Requirements

• Bachelor's degree • Minimum 2 years' relevant experience in clinical site management in study site activation • Knowledge of clinical trial methodologies, ICH/GCP, FDA regulations, and applicable global and local regulatory requirements • Experience working with Clinical Trial Management Systems (CTMS), Electronic Trial Master Files (eTMF), Electronic Investigator Site Files (eISF), and related clinical research systems • Experience supporting investigator site activation and regulatory documentation within sponsor or CRO environments • Familiarity with IRB and ethics committee processes and submissions • Experience using Shared Investigator Platform and document exchange portals • Strong organizational, documentation management, stakeholder engagement, communication, organization, problem solving, and multitasking skills • Fluent or advanced spoken and written English language skills • Quality-focused mindset, strong attention to detail, and commitment to compliance • Ability to collaborate across global teams and communicate effectively with investigator sites and study stakeholders

🏖️ Benefits

• Temporary 6-month role • Home-based work arrangement • Flexibility • Growth and continuous learning opportunities • Career growth and expanded expertise across clinical research operations

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