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Site Activation Partner - FSP - Job Opportunity at Parexel

Remote, Australia
Full-time
Mid-level
Posted: March 26, 2025
Remote
AUD 85,000 - 110,000 annually based on Australian market conditions and role requirements

Key Responsibilities

Lead and coordinate comprehensive clinical trial site activation processes, ensuring compliance with regulatory standards and timeline adherence
Manage essential document collection and validation for Investigator Initiation Packages (IIP) across multiple research sites
Drive regulatory compliance through document management and submission to ethics committees and regulatory bodies
Coordinate cross-functional communication between sites, sponsors, and internal teams to facilitate efficient trial initiation
Oversee site readiness assessment and activation processes through electronic systems and platforms

Requirements

Education

School diploma/certificate with equivalent combination of education, training, and experience. Bachelor's of Science, Bachelor's of Arts or Bachelor's in Life Sciences degree is preferred

Experience

Minimum 2 years' relevant experience in clinical site management

Required Skills

Must be fluent in local language and in English; multilingual capability is preferred Effective verbal and written communication skills Proficient in computer operations with good technical skills Microsoft Suite proficiency Clinical Trial Management Systems (CTMS) expertise Electronic Trial Master File management Electronic Investigator Site File systems knowledge Document exchange portals familiarity Shared Investigator Platform experience Ethics, National Networks and Governing Bodies Portals knowledge
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Sauge AI Market Intelligence

Industry Trends

Increasing adoption of decentralized clinical trials (DCTs) is driving demand for professionals who can manage remote site activation and coordination Growing emphasis on electronic systems and digital documentation in clinical trials is reshaping traditional site activation roles Rising regulatory complexity and global trial coordination are creating need for specialists with multi-regional expertise

Role Significance

Typically works within a team of 5-8 site activation specialists, coordinating with 20-30 research sites
Mid-level position with significant operational responsibility and cross-functional leadership requirements

Key Projects

Management of multi-site clinical trial activations requiring complex regulatory coordination Implementation of electronic systems for site documentation and compliance tracking Cross-functional project coordination between sponsors, sites, and regulatory bodies

Success Factors

Strong regulatory knowledge and ability to navigate complex compliance requirements Excellent project management skills with ability to coordinate multiple stakeholders Technical proficiency in clinical trial management systems and digital platforms Cultural competence and communication skills for global collaboration

Market Demand

High demand driven by expanding clinical trial sector in Asia-Pacific region and increasing regulatory requirements

Important Skills

Critical Skills

Regulatory compliance knowledge and GCP understanding Electronic system proficiency across multiple platforms Project management and stakeholder coordination Documentation and quality assurance expertise

Beneficial Skills

Additional language capabilities Experience with decentralized clinical trials Knowledge of emerging clinical trial technologies Understanding of regional regulatory differences

Unique Aspects

Remote work opportunity in a traditionally site-based role indicates progressive approach to clinical trial management
Strong focus on electronic systems and digital transformation in clinical trial processes
Emphasis on global collaboration and cross-cultural communication skills

Career Growth

2-3 years in role before advancement, with potential fast-track opportunities based on performance and market demand

Potential Next Roles

Clinical Operations Manager Senior Site Activation Lead Clinical Trial Project Manager Regional Start-up Manager

Company Overview

Parexel

Parexel is a leading global clinical research organization (CRO) with extensive presence in clinical trial management and biopharmaceutical services

Top-tier CRO with strong market position in Asia-Pacific region and global operations
Significant Australian presence with growing remote work capabilities
Professional environment with emphasis on regulatory compliance and quality assurance
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