Site Activation Partner – Temporary

Parexel

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

Posted 9/17/2026full-timeRemote • United KingdomJuniorMid-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 study teams to achieve operational milestones.

Highest-signal resume keywords

Clinical Site ManagementRegulatory DocumentationClinical Trial Management Systems (CTMS)Investigator Initiation PackageStakeholder Engagement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MethodologiesICH/GCP KnowledgeFDA RegulationsDocument ManagementSite ActivationRegulatory SubmissionsQuality AssuranceProcess ImprovementProblem-SolvingMultitasking

Soft Skills

Strong CommunicationOrganizational SkillsAttention to Detail

Tools & Technologies

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

Industry Keywords

Clinical ResearchIRB ProcessesEthics Committee SubmissionsSite ComplianceTrial Master File

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 assist with responses
Identify, resolve, and escalate site-related issues and support 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 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, problem-solving, and multitasking skills
Fluent or advanced spoken and written English language skills
Quality-focused mindset with strong attention to detail and commitment to compliance

Benefits

Comp & perks

6-month temporary position
Flexible working arrangements
Continuous learning opportunities
Career growth opportunities
Diverse, growth-oriented team environment