Site Activation Specialist I

• Follow project direction from the designated country start-up advisor and SAM
• Serve as a point of contact for the SAM/PM or designee during start-up on allocated projects
• Compile and/or review essential document packages for site activation
• Collect essential documents from sites
• Prepare and submit Central EC, Local EC, RA, and other local regulatory or hospital approval applications under supervision
• Prepare ongoing submissions, amendments, periodic notifications, and safety notifications required by local rules
• Liaise between investigational sites and functional leads for related tasks and issues
• Oversee the end-to-end site activation process at country/site level
• Support site selection and feasibility activities with the site selection lead and PM/SAM
• Support country template contract and budget negotiations
• Assist in producing site-specific contracts
• Assist with budget and contract negotiations with sites, the Site Contracts Service Centre, SAM lead, and Sponsor
• Assist with quality control and execution of clinical trial agreements
• Archive documents into repositories and capture metadata

• Associate’s Degree or equivalent combination of education and training
• Good understanding of clinical trial process across Phases II-IV and ICH GCP
• Ability to interact effectively and appropriately with investigative site personnel
• Good organizational skills and attention to detail, with proven ability to handle multiple tasks effectively
• Ability to take direction from multiple individuals and set priorities accordingly
• Ability to effectively communicate across multiple function groups (clinical team, PM, Director)
• Demonstrated ability to work independently and as part of a team
• Ability to utilize problem-solving techniques effectively
• Quality-driven in all managed activities
• Flexibility and willingness to adapt to a rapidly changing environment and learn/perform new functions
• Strong computer skills, including Word, Excel, PowerPoint, Publisher

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Reasonable accommodations when appropriate