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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in site start-up strategies, including the development and alignment of site activation projections, while ensuring compliance with regulatory guidelines. Proficient in leveraging data-driven insights for optimized site selection and effective vendor management.
Highest-signal resume keywords
Site Start-Up Strategy DevelopmentClinical Drug Development ProcessTrial Management Systems (CTMS, TMF)Data-Driven Decision MakingInterpersonal & Leadership Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site Activation ProjectionsStudy Metrics AnalysisRegulatory Submissions SupportSite Intelligence CollectionVendor Management
Soft Skills
Effective CommunicationInfluencing & NegotiationProblem Solving
Tools & Technologies
CTMSTMFMS ProjectMS PowerPointMS WordMS Excel
Industry Keywords
ICHGCPRegulatory GuidelinesCross-Functional CollaborationGlobal Country Start-Up Strategy
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Develop the site start up strategy for each study, outlining all dependencies impacting site activation
- Oversee the tracking and analysis of study metrics, including risks and mitigation strategies
- Advocate for optimized site selection strategies, leveraging data-driven insights
- Lead the development, assessment, and alignment of site activation projections
- Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF)
- Partner with cross functional and CRO partners to develop a comprehensive global country start up strategy
- Monitor and maintain country intelligence data to support informed decision-making
- Support regulatory submissions as needed
- Lead and oversee all aspects of site start-up activities
- Serve as the subject matter expert for essential site documents
- Oversee the collection and analysis of site intelligence to support strategic site selection and site start-up
- Represent SSU on cross-functional teams
Requirements
What you’ll need- 4-6 years of experience
- Demonstrated interpersonal & leadership skills
- A data driven approach to planning, executing, and problem solving
- Effective communication skills via verbal, written and presentation abilities
- Ability to influence and negotiate across key stakeholders
- Experience in the clinical drug development process, with expertise in study start-up
- Demonstrated vendor management experience
- Technical proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel
- Knowledge of ICH/GCP and regulatory guidelines/directives
Benefits
Comp & perks- Health insurance
- Remote work options
