Site Activation Leader

This is a fully remote position, open to applicants in China.

📋 Description

• Lead the planning and strategy development for site activation in assigned clinical studies.

• Oversee milestones and deliverables related to site activation, from feasibility through to the final site activation.

• Monitor and report on the progress of site activation across various studies, addressing any delays or risks that may arise.

• Direct cross-functional teams to tackle challenges related to site activation.

• Develop, coordinate, and implement critical path plans for studies that encompass site feasibility, selection, regulatory approvals, initiation, activation, system setup, TMF/EDL management, EC and RA/MoH strategy, ICF customization, risk mitigation, and relevant tools, documents, and reporting.

• Provide support and guidance to members of the site activation team.

• Act as a liaison among project management, site start-up teams, and site activation functions.

• Lead internal communications regarding the status and actions of site activation.

• Coordinate with clinical operations leadership to ensure alignment with study objectives.

• Manage client relationships and communication concerning timelines and deliverables.

• Serve as the Subject Matter Expert for Study Start-Up regarding specific client accounts.

• Assist in business development by leveraging site activation expertise during proposals and bid pursuit meetings.

• Implement standardized processes and best practices for site activation.

• Analyze metrics related to site activation to enhance process optimization.

• Ensure adherence to regulatory requirements and company Standard Operating Procedures (SOPs).

• Contribute to the development of site activation procedures and templates.

• Advocate for quality initiatives.

• Lead the use of CTMS, EDC, IXRS, and TMF systems.

• Oversee the documentation of site activation processes and their outcomes.

• Optimize project planning systems to improve timelines and resource allocation.

• Ensure the integrity of data and the maintenance of systems.

• Generate strategic reports and metrics for review by leadership.

⛳️ Requirements

• 4–7 years of experience in clinical research operations with a focus on site activation leadership.

• Proven track record of leading site activation teams and managing related processes.

• Extensive knowledge of the start-up processes and requirements for clinical trials.

• Strong background in ensuring regulatory compliance within clinical research.

• Significant experience collaborating with clinical research sites and investigators.

• Demonstrated knowledge of clinical trial timelines and milestones management.

• Experience in process improvement and team leadership.

• Bachelor's degree in Life Sciences, Healthcare, Business Administration, or a related field.

• High proficiency in CTMS, EDC, IXRS, and TMF systems.

• Strong understanding of project planning and management software.

• Comprehensive knowledge of clinical trial regulations and Good Clinical Practice.

• In-depth understanding of site activation processes and requirements.

• Extensive familiarity with clinical research operations and workflows.

• Advanced skills in project management and strategic planning.

• Excellent written and verbal communication skills, particularly with senior stakeholders.

• Strong management and leadership capabilities.

• Exceptional problem-solving and critical thinking skills.

• Keen attention to detail and accuracy in managing complex documentation.

• Strong time management skills with the ability to prioritize multiple complex projects.

• Proven cross-functional leadership and coordination abilities.

• Expertise in change management and process improvement.

• Experience in client relationship management and supporting business development efforts.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health insurance, including medical, dental, and vision coverage.

• Opportunities for professional development and career advancement.

• Flexible work hours and remote work options.

• Generous paid time off and holiday policy.

• Retirement savings plan with company matching.