Overview
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.
Leistungen / Benefits
- career development and progression
- inclusive culture
- supportive line management
- technical and therapeutic area training
- peer recognition
- total rewards program
Verantwortungsbereiche
- 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
Zentrale Anforderungen
- 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
Site Activation Specialist in Ingolstadt Arbeitgeber: Syneos Health
Syneos Health ist ein hervorragender Arbeitgeber, der sich leidenschaftlich für die Entwicklung seiner Mitarbeiter einsetzt und eine inklusive Unternehmenskultur fördert, in der jeder authentisch sein kann. Mit einem starken Fokus auf Karriereentwicklung, technische Schulungen und Anerkennung bietet das Unternehmen zahlreiche Möglichkeiten zur persönlichen und beruflichen Entfaltung. In Nordostdeutschland gelegen, profitieren Mitarbeiter von einem dynamischen Arbeitsumfeld, das Innovation und Zusammenarbeit fördert, um gemeinsam bedeutende Fortschritte im Gesundheitswesen zu erzielen.
