Site Activation Specialist

In this Site Activation Specialist role, you will oversee site start-up activities at the country level, ensuring timely regulatory submissions, document completeness, and TMF accuracy. You’ll collaborate with country leaders, CSA, and PM/SAM to drive end-to-end activation while managing timelines and quality. You will contribute to continuous improvement of SSU processes, support budget and contract activities, and act as a primary liaison for investigative sites. This position offers an opportunity to impact trial initiation across countries within a global clinical solutions team.

• career development and progression
• inclusive culture
• supportive line management
• technical and therapeutic area training
• peer recognition
• total rewards program

• Ensure country-level quality of SSU deliverables and adherence to timelines
• Track milestones in real-time and provide remediation for delays with contingency plans
• Monitor basic project finances and escalate discrepancies
• Maintain SOPs/WIs and training records; ensure timesheet compliance
• Contribute to continuous improvement of SSU components (submissions, essential documents, communications)
• Submit documents to the Trial Master File (TMF) per SOP/sponsor requirements
• Serve as Local Submissions Specialist; liaise with CSA and SAM during start-up
• Prepare and submit local and central regulatory submissions (EC/RA) and other local approvals
• Coordinate site activation end-to-end at country/site level
• Provide country-level regulatory intelligence and support data protection discussions as needed
• Assist with siteID and feasibility activities to ensure appropriate site selection
• Support local investigator contracts and budget negotiations; draft site contracts and manage approvals and archival of documents
• Ensure quality control and metadata capture for CTAs and related paperwork

• Bachelor’s Degree
• understanding of clinical trial processes across Phases II–IV and ICH GCP
• ability to manage external vendors and contracts
• strong organizational skills with multi-tasking ability
• excellent written and verbal communication and interpersonal skills
• ability to manage multiple budgets with increasing complexity
• quality-driven work approach
• strong negotiation and problem-solving skills
• ability to work independently and in a team
• familiarity with site start-up processes and regulatory submissions

• strong communication
• interpersonal skills
• negotiation
• knowledge of regulatory submissions (EC/RA) and local approvals
• experience with TMF/document management
• familiarity with SOPs/WIs and QA processes