Senior Site Activation Specialist
Syneos Health
Adelaide
1 week ago
Senior Site Activation Specialist
Senior Site Activation Specialist responsible for site start-up of investigative sites in clinical trials. Manages regulatory submissions, contracts, and essential documents at the country level. Requires minimal oversight and ensures compliance with timelines and quality standards.
Remote
Full-time
Senior
TMF
SOPs
Salary
Not specified
Core Qualifications
Soft Skills
communicationproblem solvingmentoringorganizational skillsattention to detailtime managementcollaborationanalytical skills
Tools (Must-have)
TMFSOPsWIsclinical trial management systems
Key Responsibilities
- Responsible for quality deliverables at the country level; follows project requirements and applicable country rules.
- Forecasts submission/approval timelines, ensures compliance and tracks milestone progress in agreed upon SSU tracking system.
- Monitors financial aspects of the project and the number of hours/tasks available per contract.
- Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI).
- Ensures all relevant documents are submitted to the Trial Master File (TMF).
- Compiles and/or reviews essential document packages for site activation.
- Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authority submissions.
- Oversees ongoing submissions, amendments, and periodic notifications required by central and local EC and RA.
- May act as liaison and facilitator between investigational sites and functional leads.
- Acts as Country Start-Up Advisor and subject matter expert for in-country performance within Site Start-Up.
Senior Site Activation SpecialistClinical TrialsSite Start-UpRegulatory SubmissionsEthics CommitteesSyneos HealthRemoteFull-timeLife SciencesBiotechnology