Site Monitoring Lead – Clinical Operations

This is a fully remote position, open to applicants in Germany.

📋 Description

• Oversee the creation and implementation of site monitoring and oversight strategies at the trial level, including risk assessments and site monitoring plans.

• Supervise CRO-provided site management and monitoring activities to guarantee quality, compliance, and timely execution of studies.

• Perform trial-level trend analysis, signal detection, risk identification, and issue management to facilitate proactive decision-making.

• Promote a risk-based approach to site monitoring, ensuring that all monitoring activities are in alignment with study objectives and quality standards.

• Work collaboratively with Clinical Trial Managers, Clinical Research Associates, and cross-functional stakeholders to ensure study delivery meets milestones and key performance indicators.

• Assist in the creation and upkeep of trial-level documents, amendments, training materials, and procedures related to monitoring.

• Lead and engage in trial oversight meetings, investigator meetings, and cross-functional study discussions on global, regional, and local scales.

• Conduct site and monitoring oversight activities, implement follow-up actions, and escalate issues when necessary.

• Act as a subject matter expert in site management and monitoring, offering guidance and training to study teams.

• Aid in trial closeout activities, including the coordination of clinical data delivery and contributing to the quality sections of clinical study reports.

• Ensure timely responses to monitoring-related inquiries from internal stakeholders, CRO partners, regulatory authorities, and ethics committees.

• Maintain inspection readiness and continuous compliance with sponsor obligations, ICH GCP guidelines, SOPs, and regulatory requirements.

⛳️ Requirements

• A university degree (Bachelor's or equivalent) in life sciences or a related field, or several years of equivalent professional education combined with substantial experience in site monitoring and management.

• Multiple years of experience in site monitoring, site management, clinical trial operations, or a related clinical research area.

• Proven scientific and operational expertise in all aspects of clinical trial planning, site monitoring, and execution.

• In-depth knowledge of ICH GCP, regulatory requirements, sponsor oversight responsibilities, and clinical trial processes.

• Demonstrated ability to manage complex clinical trials involving multiple sites, countries, vendors, and stakeholders.

• Strong skills in communication, organization, training, and problem-solving.

• Proficiency in the English language, both written and spoken.

• Extensive knowledge in site monitoring, clinical trial oversight, and risk-based quality management.

• Experience in global clinical development and regulated research environments.

• Capability to influence and collaborate effectively across complex cross-functional and matrix teams.

• Patient-focused mindset with a commitment to quality, compliance, and operational excellence.

• Excellent communication, leadership, and stakeholder management abilities.

• Aptitude for identifying risks, addressing complex challenges, and driving favorable study outcomes.

• Strong organizational skills and attention to detail within dynamic global clinical programs.

🏝️ Benefits

• Health, Vision & Dental Insurance

• Vacation/Holiday/Sick Time

• Flexible benefit portal

• Flexible work arrangement (Remote)