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Senior Project Specialist, Single Sponsor
Syneos Health. Set up, maintain, and close out project files and study information, including KPIs, regulatory documents, TMF, enrollment, adverse events, protocol deviations, site supplies, IRB re-approvals, and data queries .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in project file management, KPI assessment, and quality assurance activities while effectively leading meetings and mentoring team members. Proficient in maintaining study-specific reports and ensuring compliance with archiving guidelines.
Highest-signal resume keywords
Project File ManagementKPI AssessmentQuality Assurance SupportMeeting LeadershipMentoring Project Specialists
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project File SetupKPI RecordingStudy Document ArchivingFinancial ReportingAudit Preparation
Soft Skills
Team CollaborationAction Item Follow-UpCustomer Support
Industry Keywords
Regulatory DocumentsTMFIRB Re-approvalsAdverse EventsProtocol Deviations
About the role
Key responsibilities & impact- Set up, maintain, and close out project files and study information, including KPIs, regulatory documents, TMF, enrollment, adverse events, protocol deviations, site supplies, IRB re-approvals, and data queries
- Maintain and distribute study-specific and financial reports, including vendor/site invoices, investigator payments, forecasts, and related information
- Lead internal and external meetings as directed by the Project Lead; prepare and distribute meeting minutes and action items
- Follow up with team members on action items through closure
- Record KPI status, assess and communicate KPIs, and propose action plans with Project Lead oversight
- Prepare and provide customer status reports with Project Lead oversight
- Ensure study documents are archived according to applicable guidelines and policies
- Serve as project representative for internal and external audits when required
- Support quality assurance activities, audit preparation, internal reviews, and resolution of actionable issues
- Serve as primary customer contact when the Project Lead is out of office, seeking Project Director input as needed
- Mentor and train Project Specialists
Requirements
What you’ll need- Equivalent experience, skills, and/or education will be considered
- Ability to set up, maintain, and close out project files and study information across databases and systems
- Ability to maintain and distribute study-specific and financial reports
- Ability to lead or support internal and external meetings and follow up on action items
- Ability to record and assess KPIs and prepare status reports
- Knowledge of study document archiving guidelines and policies
- Ability to support quality assurance activities and audits
- Ability to provide customer support and mentor/train Project Specialists
Benefits
Comp & perks- 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