Site Activation Leader
Parexel
Summary
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.
Job description
Key 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.
Candidate Profile
- 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
Required 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
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
Benefits
- Health Insurance
- Vision Insurance
- Dental Insurance
- Tuition Reimbursement
- Vacation Time
- Holiday Time
- Sick Time
- Flexible Spending Accounts
- Health Savings Accounts
- 401(k) with Company Match
- Pet Insurance
- Life Insurance
- Work/Life Balance
Company overview
Parexel is one of the world's largest and most prominent contract research organizations (CROs), providing comprehensive clinical research services to pharmaceutical and biotechnology companies globally. Founded in 1982 and headquartered in Raleigh, North Carolina, Parexel operates with a global workforce of over 24,000 professionals across 84+ facilities in 49 countries. The company specializes in managing the full spectrum of clinical trials from Phase I to IV across diverse therapeutic areas including neuroscience, oncology, infectious diseases, hematology, and general medicine. Parexel offers end-to-end solutions encompassing clinical trial management, regulatory strategy, data management, biostatistics, pharmacovigilance, medical communications, and market access consulting. With a strong track record spanning over 40 years, Parexel has established itself as a trusted partner for both established pharmaceutical leaders and emerging biotech innovators, helping accelerate drug development and bring life-saving treatments to patients faster through its patient-centric approach and operational excellence.