Site Activation Specialist
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Job Description
Site Activation Specialist supporting Canadian clinical-trial submissions, regulatory approvals, contracts, and end-to-end site activation for Syneos Health.
Responsibilities:
- Provide quality oversight of country-level deliverables under the SSU Country Manager
- Track submission and approval milestones in the agreed SSU tracking system in real time
- Provide rationale for delays, assist with contingency plans, and escalate issues
- Monitor project financial aspects and contracted hours/tasks; escalate discrepancies
- Review and comply with SOPs and WIs; maintain training records and timesheet compliance
- Submit relevant documents to the Trial Master File
- Compile and/or review essential document packages for site activation
- Collect essential documents from sites when required
- Prepare and submit ethics committee, regulatory authority, and hospital approval applications
- Prepare ongoing submissions, amendments, periodic notifications, and safety notifications
- Liaise between investigational sites and functional leads
- Oversee the end-to-end site activation process at country/site level
- Support site selection and feasibility with the site selection lead and PM/SAM
- Support investigator contract and budget negotiations, CTA execution, document archival, and metadata capture
Requirements:
- Equivalent experience, skills, and/or education will also be considered
- Must follow project requirements and applicable country rules
- Must work within forecasted submission/approval timelines
- Must comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs)
- Must maintain updated training records and ensure timesheet compliance
- Must ensure relevant documents are submitted to the Trial Master File (TMF) according to Company SOP/Sponsor requirements
- Ability to prepare and submit Central EC, Local EC, RA, regulatory authority, and hospital approval applications as required
- Ability to prepare ongoing submissions, amendments, periodic notifications, and safety notifications according to local rules
- Ability to support site selection and feasibility activities
- Ability to assist with country template contracts, site-specific contracts, budget and contract negotiations, CTA quality control, execution, archival, and metadata capture
Benefits:
- 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, for employees or applicants with disabilities
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