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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates strong analytical and investigative skills essential for evaluating regulatory compliance and performance information. Proficient in managing the end-to-end site activation process while ensuring accuracy in documentation and effective communication with stakeholders.
Highest-signal resume keywords
Regulatory Compliance AssessmentSite Activation Process ManagementContract and Budget Negotiation SupportRisk Identification and EscalationAttention to Detail
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Authority ApplicationsEthics Committee ApplicationsDocument Review and CompilationQuality ControlData Entry Accuracy
Soft Skills
Analytical MindsetOrganizational SkillsTime ManagementClear Written CommunicationProfessional Judgment
Industry Keywords
Clinical TrialSite SelectionStudy Start-UpOngoing Study DeliveryEssential Document Packages
About the role
Key responsibilities & impact- Support site and investigator evaluation activities
- Collect, review, and assess regulatory, compliance, quality, and performance information
- Support site selection, study start-up, and ongoing study delivery
- Identify potential risks and escalate concerns
- Collaborate with internal stakeholders to ensure timely resolution
- Follow project direction from the designated country start-up advisor and Site Activation Manager
- Compile and/or review essential document packages for site activation
- Collect essential documents from sites
- Prepare and submit central and local ethics committee applications, regulatory authority applications, and other local approval submissions under supervision
- Prepare ongoing submissions, amendments, periodic notifications, and safety notifications as required
- Liaise between investigational sites and functional leads
- Oversee the end-to-end site activation process at country and site level
- Support site selection based on clinical trial requirements
- Assist with country-template and site-specific contracts and budgets
- Support contract and budget negotiations under supervision
- Assist with quality control, execution of clinical trial agreements, document archival, and metadata capture
Requirements
What you’ll need- Strong analytical and investigative mindset
- Ability to review information from multiple sources and identify potential risks
- Excellent attention to detail
- Commitment to accuracy in documentation and data entry
- Sound professional judgment
- Ability to distinguish factual findings, items of note, and potential significant or disqualifying findings
- Ability to follow established processes and recognize when escalation is required
- Strong organizational and time management skills
- Ability to manage competing priorities and meet deadlines
- Clear written communication skills
- Ability to document rationale, evidence, and outcomes concisely and traceably
- Comfortable with repetitive work and structured processes
- Ability to maintain quality and focus while performing similar assessments repeatedly
- 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