Remote Site Activation Leader | Study Start-Up Expert

Parexel; Saint Paul (MN); Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health Insurance

Vision Insurance

Dental Insurance

Tuition Reimbursement

Vacation & Sick Time

FSA/HSA

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Site Activation Leader to join our team, providing expert planning and oversight for clinical trial programs and multiple studies, driving on-time initiation of clinical research sites. This role supports cross-functional collaboration with project management, operations, clients, and investigative sites.

You will guide study activation from feasibility to activation, coordinate critical path activities, and contribute to optimized site initiation across therapeutic areas in

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 or Ministry of Health 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 Standard Operating Procedures, and contribute to the development and maintenance of site activation procedures and templates.
• Lead the use of Clinical Trial Management System, Electronic Data Capture, Interactive Response Technology, and Trial Master File 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

Regulatory compliance

Clinical trial operations

Project management

Stakeholder communication

Process improvement

Education

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

Tools

Job description

Parexel is seeking a Site Activation Leader to join our team, providing expert planning and oversight for clinical trial programs and multiple studies, driving on-time initiation of clinical research sites. This role supports cross-functional collaboration with project management, operations, clients, and investigative sites.

You will guide study activation from feasibility to activation, coordinate critical path activities, and contribute to optimized site initiation across therapeutic areas in