Site Activation Partner – Study Start-Up Associate

• Initiate and coordinate clinical trial site activation activities and essential document management
• Compile high-quality Investigator Initiation Packages leading to site initiation approval
• Resolve or escalate site issues in a timely manner
• Prepare, validate, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms
• Coordinate supporting roles and activities to ensure timely site activation
• Support central and local ethics committee packages, submissions, communications, and approvals
• Support investigators with local IRB workflows from preparation through approval
• Prepare, handle, and distribute clinical documentation and reports according to scope of work and SOPs
• Support and implement activities in the Shared Investigator Platform
• Manage site documentation and updates throughout study conduct, including protocol amendments, FDA 1572/Attestation revisions, and ethics committee annual approvals
• Maintain IRB/Ethics and other committee activities as applicable
• File documents to the Trial Master File and assist with periodic quality reviews
• Update and maintain clinical trial systems tracking site compliance and performance
• Support investigator sites and study teams during audits and inspections
• Maintain communication with study teams and investigator sites and respond to requests
• Provide country- and site-level functional updates and establish tools for efficient status reporting
• Disseminate central and local ethics approvals to study teams and investigator sites
• Conduct awareness sessions on client requirements and ongoing documentation compliance as needed
• Identify and resolve site issues and coordinate corrective and preventative actions
• Serve as a Site Activation Partner point of contact, subject matter expert, mentor, or representative on initiatives as assigned
• Complete required training, timesheets, expense reports, and CV updates
• Maintain compliance with Parexel processes, ICH-GCP, and applicable requirements

• Knowledge of clinical research and development processes and key operational elements of a clinical trial
• Understanding of quality expectations and emphasis on right first time
• Compliance with applicable company, regulatory, and country requirements
• Disciplined attention to detail
• Ability to work independently and as a team member
• Ability to organize tasks, time, and priorities and multitask
• Basic medical terminology and GCP requirements
• Proficient in computer operations and able to learn and use systems independently
• Microsoft Suite
• Clinical Trial Management Systems (CTMS)
• Electronic Trial Master File and Electronic Investigator Site File systems, e.g. Florence
• Document exchange portals
• Shared Investigator Platform
• Ethics, national networks, and governing bodies portals and platforms as needed
• Flexibility for off-hours work in a global environment when applicable
• Able to travel as needed, including possible international travel
• Experience in the pharmaceutical industry or CRO in study site activation preferred
• Knowledge of clinical trial methodologies, ICH/GCP, FDA, and global and local country regulations
• Fluent in the local language and English
• Multilanguage capability preferred
• Effective verbal and written communication skills
• Good technical skills and ability to learn and use multiple systems
• School diploma or certificate with equivalent combination of education, training, and experience, or Bachelor of Science/Bachelor of Arts or equivalent
• Minimum 2 years of relevant experience in clinical site management
• Education in a life sciences discipline preferred

• No benefits, perks, or compensation extras are specified in the posting