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Site Activation Manager – Sponsor Dedicated
Syneos Health. Manage a portfolio of Clinical Trial Applications, including preparation and distribution of documentation for initial CTAs and maintenance activities such as substantial amendments and end-of-trial notifications .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing Clinical Trial Applications (CTAs) and navigating EU Clinical Trials Regulation (EU CTR) submissions, with a strong focus on submission strategy, regulatory compliance, and cross-functional team guidance. Proficient in maintaining regulatory databases and ensuring inspection readiness.
Highest-signal resume keywords
Clinical Trial Applications ManagementEU Clinical Trials Regulation KnowledgeCross-Functional Team GuidanceRegulatory Submission StrategyInspection Readiness Activities
ATS Keywords
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Hard Skills
Clinical Trial Applications ManagementSubmission StrategyEU Clinical Trials RegulationRegulatory Submission PreparationClinical Trial Document ReviewRegulatory Database MaintenanceProject Milestone MonitoringScientific Advice ProceduresRegulatory IntelligenceActivity Tracking
Soft Skills
Training and EducationStakeholder CommunicationProblem-Solving
Industry Keywords
Clinical TrialsRegulatory ComplianceInspection ReadinessCross-Functional CollaborationRegulatory Submissions
About the role
Key responsibilities & impact- Manage a portfolio of Clinical Trial Applications, including preparation and distribution of documentation for initial CTAs and maintenance activities such as substantial amendments and end-of-trial notifications
- Advise on submission strategy and country requirements
- Provide operational support for regulatory submission preparation and amendment processing
- Serve as subject matter expert on EU CTR submissions, including platform and complex trials
- Guide cross-functional teams through EU CTR processes and provide training and education
- Define strategies for CTR transitions and initial submissions with key stakeholders
- Lead CTA-specific scientific advice procedures
- Review and provide input on clinical trial submission documents managed by other stakeholders, including Investigator Brochures and protocols
- Ensure approved CTA processes are followed within agreed timelines
- Monitor project milestones and communicate issues or changes to stakeholders and management
- Support inspection readiness activities
- Review regulatory intelligence and advise stakeholders
- Maintain regulatory databases and activity trackers and support critical regulatory and non-regulatory systems
Requirements
What you’ll need- Experience managing Clinical Trial Applications (CTAs), including initial submissions and CTA maintenance activities
- Knowledge of submission strategy and country requirements
- Knowledge of EU Clinical Trials Regulation (EU CTR) submissions, including platform and complex trials
- Ability to guide cross-functional teams through EU CTR processes and provide training and education
- Experience defining strategies for CTR transitions and initial submissions
- Experience leading CTA-specific scientific advice procedures
- Ability to review clinical trial submission documents, including Investigator Brochures and protocols
- Good understanding of the CTR process and requirements
- Ability to monitor project milestones, timelines, issues, and changes
- Knowledge of inspection readiness activities
- Awareness of regulatory intelligence relating to clinical trials
- Ability to maintain regulatory databases and activity trackers
- Equivalent experience, skills, and/or education will also be considered
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, to assist employees or applicants with disabilities