Site Activation Leader

🔥 1 minute ago

🇨🇳 China – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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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

• Lead site activation planning and strategy development for assigned clinical studies • Oversee site activation milestones and deliverables from site feasibility through last site activation • Monitor and report site activation progress across multiple studies and mitigate delays or risks • Lead cross-functional teams to resolve site activation challenges • Develop, coordinate, and execute study critical path plans covering site feasibility, site selection, regulatory green light, site initiation, site activation, system setup, TMF/EDL management, EC and RA/MoH strategy, ICF customization, risk mitigations, and related tools, documents, and reporting • Provide guidance to site activation team members • Liaise between project management, site start-up teams, and site activation functions • Lead internal communication on site activation status and actions • Coordinate with clinical operations leadership to align activities with study objectives • Manage client relationships and communication regarding timelines and deliverables • Serve as Study Start-Up Subject Matter Expert for designated client accounts • Support business development through site activation expertise in proposals and bid pursuit meetings • Implement standardized site activation processes and best practices • Analyze site activation metrics and drive process optimization • Ensure compliance with regulatory requirements and company SOPs • Contribute to site activation procedures and templates • Champion quality initiatives • Lead use of CTMS, EDC, IXRS, and TMF systems • Oversee documentation of site activation processes and outcomes • Optimize project planning systems for timelines and resource allocation • Ensure data integrity and system maintenance • Generate strategic reports and metrics for leadership review

🎯 Requirements

• 4–7 years of experience in clinical research operations with site activation leadership • Proven experience leading site activation teams and processes • Comprehensive knowledge of clinical trial start-up processes and requirements • Strong background in regulatory compliance in clinical research • Extensive experience working with clinical research sites and investigators • Demonstrated understanding of clinical trial timelines and milestone management • Experience with process improvement and team leadership • Bachelor's degree in Life Sciences, Healthcare, Business Administration, or related field • Excellent proficiency with CTMS, EDC, IXRS, and TMF systems • Strong project planning and management software knowledge • Comprehensive knowledge of clinical trial regulations and Good Clinical Practice • Deep understanding of site activation processes and requirements • Extensive familiarity with clinical research operations and workflows • Advanced project management and strategic planning abilities • Excellent written and verbal communication skills with senior stakeholders • Strong management capabilities • Excellent problem-solving and critical thinking skills • Attention to detail and accuracy in complex documentation • Excellent time management and ability to prioritize multiple complex projects • Cross-functional leadership and coordination • Change management and process improvement expertise • Client relationship management and business development support