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When our values align, there's no limit to what we can achieve.
At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
Accountability
Supporting Activities
Site Activation Leadership and Strategy
Lead site activation planning and strategy development for assigned clinical studies
Oversee site activation milestones and deliverables to ensure timely and quality study start-up from site feasibility through last site activation
Monitor and report on site activation progress across multiple studies and mitigate potential delays or risks
Lead cross-functional teams to resolve complex site activation challenges and issues
Develop, coordinate, and execute the study critical path plan. This includes but is not limited to Site Feasibility, Site Selection, Regulatory Green Light, Site Initiation, and Site Activation, as well as System Set-up, pertinent TMF/EDL Management, EC & RA/ MoH Strategy, ICF Customization, Risk Mitigations, Site Activation Requirements & Relevant Tools, Documents, and Reporting
Team Leadership and Stakeholder Management
Provide guidance to site activation team members
Serve as liaison between project management, site start-up teams, and site activation functions
Lead regular communication with internal teams regarding site activation status and actions
Coordinate with clinical operations leadership to align site activation activities with overall study objectives
Manage client relationships and communication regarding site activation timelines and deliverables
Client Relationship Management and Business Development
Serve as the Study Start-Up (SSU) Subject Matter Expert (SME) for designated client accounts, providing strategic guidance, best practice recommendations, and technical expertise to ensure optimal study initiation and site activation outcomes
Support business development activities by providing site activation expertise in proposals and bid pursuit meetings (BPMs)
Process Development and Quality Leadership
Implementation of standardized site activation processes and best practices across studies
Analyze site activation metrics and drive process optimization initiatives
Ensure compliance with regulatory requirements and company SOPs during site activation
Contribute to the development and maintenance of site activation procedures and templates
Champion quality initiatives to enhance site activation efficiency and effectiveness
System Leadership and Strategic Documentation
Lead utilization of CTMS, EDC, IXRS, and TMF systems to optimize site activation workflows
Oversee accurate documentation of site activation processes and outcomes across studies
Drive project planning system optimization related to site activation timelines and resource allocation
Ensure proper data integrity and system maintenance for assigned portfolio
Generate strategic reports and metrics using clinical trial management systems for leadership review
Skills:
Excellent proficiency with CTMS, EDC, IXRS, and TMF systems
Strong project planning and management software
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
Knowledge and Experience:
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
Education:
Bachelor's degree in Life Sciences, Healthcare, Business Administration, or related field
Advanced training and experience in clinical operations, site management, and/or project management preferred
