Remote Site Activation Leader – Start-Up Expert

Parexel; Santa Fe (NM); Remote; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health Vision Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Site Activation Leader to join our team working remotely. You will provide expert planning and oversight for clinical trial programs, driving on-time initiation of sites and leading activation activities from feasibility through activation.

You will coordinate cross-functional teams, manage timelines, and ensure high-quality study start-up. This role emphasizes strategic planning, regulatory compliance, and collaboration with clients and investigative sites.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, Business Administration, or a related field.
• 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.
• Excellent written and verbal communication skills with senior stakeholders.

Responsibilities

• Lead site activation planning and strategy development for assigned clinical studies, overseeing milestones and deliverables from site feasibility through last site activation.
• Develop, coordinate, and execute the study critical path plan, including site feasibility, site selection, Regulatory Green Light, site initiation, site activation, system setup, Trial Master File and Expected Document List management, ethics committee and regulatory authority strategy, informed consent form customization, risk mitigation, activation requirements, tools, documents, and reporting.
• Monitor and report site activation progress across multiple studies, identify potential delays and risks, and lead cross-functional teams in resolving complex activation challenges.
• Provide guidance to site activation team members and serve as a liaison among project management, site start-up teams, site activation functions, and clinical operations leadership.
• Manage client relationships and communications regarding site activation timelines and deliverables, and serve as the Study Start-Up Subject Matter Expert for designated client accounts.
• Provide strategic guidance, best practice recommendations, and technical expertise to support optimal study initiation and site activation outcomes.
• Support business development activities by contributing site activation expertise to proposals and bid pursuit meetings.
• Implement standardized site activation processes and best practices, analyze activation metrics, and drive process optimization and quality initiatives.
• Ensure compliance with regulatory requirements and company SOPs, and contribute to the development and maintenance of site activation procedures and templates.
• Lead the use of CTMS, EDC, IRT, and TMF systems to optimize site activation workflows.
• Oversee accurate documentation, data integrity, system maintenance, timeline planning, and resource allocation across the assigned portfolio.

Skills

Site activation leadership

Strategic planning

Cross-functional coordination

Project management

Communication with senior stakeholders

Education

Bachelor's degree in Life Sciences/Healthcare/Business Administration or related field

Job description

Parexel is seeking a Site Activation Leader to join our team working remotely. You will provide expert planning and oversight for clinical trial programs, driving on-time initiation of sites and leading activation activities from feasibility through activation.

You will coordinate cross-functional teams, manage timelines, and ensure high-quality study start-up. This role emphasizes strategic planning, regulatory compliance, and collaboration with clients and investigative sites.