Site Monitoring Lead – Clinical Operations Lead
Parexel
full-time
Posted on:
Location Type: Remote
Location: Germany
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Job Level
Tech Stack
About the role
- Working as a Site Monitoring Lead you will be a key member of the global Clinical Trial Team
- SMLs are accountable for authoring the monitoring risk assessments and plans
- Ensuring sponsor oversight, trend analysis, signal detection and delivery of your assigned trials in close collaboration with the CRO partner
- Safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, sponsor obligations, ICH-GCP and applicable regulations
- Coordinating timely cleaning and delivery of clinical trial data with Trial Team and countries
Requirements
- University (e.g., bachelor’s or comparable degree) in life sciences or related field OR several years of equivalent professional education may be acceptable if complemented by solid knowledge in and experience with Site Monitoring and Site Management processes and accountabilities
- Demonstrated scientific and therapeutic knowledge and operational expertise across all Site Monitoring aspects in clinical trial planning and execution
- Understand dimensions of trial complexity include protocol, patients, sites, countries, vendors
Benefits
- health insurance
- paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
monitoring risk assessmentstrend analysissignal detectionclinical trial data cleaningclinical trial planningsite monitoring processessite management processescompliance with study protocolICH-GCPregulatory compliance
Soft Skills
collaborationaccountabilitycommunicationorganizational skillsproblem-solving