Site Activation Partner – FSP

Parexel

. Lead and coordinate site activation activities and essential document management for timely site initiation and study start-up .

Posted 9/17/2026full-timeRemote • FranceJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical site management, including site activation, regulatory documentation, and compliance with ICH/GCP and FDA regulations. Proficient in managing clinical trial systems and fostering collaboration among global teams to ensure successful study execution.

Highest-signal resume keywords

Clinical Site ManagementRegulatory DocumentationClinical Trial Management Systems (CTMS)Investigator Initiation PackageICH/GCP Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MethodologiesRegulatory RequirementsDocument ManagementSite ActivationFDA 1572IRB SubmissionsTrial Master File ManagementProblem SolvingMultitaskingQuality Assurance

Soft Skills

Strong CommunicationStakeholder EngagementOrganizational SkillsAttention to DetailCollaboration

Tools & Technologies

Electronic Trial Master Files (eTMF)Electronic Investigator Site Files (eISF)Shared Investigator PlatformDocument Exchange Portals

Industry Keywords

Clinical ResearchSite ActivationCRO EnvironmentsEthics Committee ProcessesGlobal Regulatory Compliance

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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