Site Activation Leader

Parexel•Southport, NC

2d•Remote

About The Position

We are seeking a Site Activation Leader (Study Start-Up Lead, Site Start-Up Lead) to join our team working remotely. As a Site Activation Leader, you will provide expert planning and functional oversight for clinical trial programs and individual studies, driving operational excellence and the on-time, high-quality initiation of clinical research sites. You will lead site activation activities from feasibility through activation, coordinate the study critical path, and help enable efficient study conduct and enrollment across multiple studies and therapeutic areas. You will join a collaborative, growth-oriented environment where your leadership will connect project management, site start-up teams, clinical operations, clients, and investigative sites. Through strategic planning, cross-functional coordination, process optimization, and quality oversight, you will strengthen site activation delivery and contribute directly to the successful execution of clinical research.

Requirements

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
Strengths in site activation leadership, strategic planning, and cross-functional coordination
Comprehensive knowledge of clinical trial regulations, Good Clinical Practice, site activation processes, and clinical research operations
Advanced project management, critical thinking, problem-solving, and process improvement capabilities
The ability to communicate effectively with senior stakeholders, clients, investigative sites, and cross-functional teams
Strong attention to detail and accuracy in complex clinical trial documentation

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.