Key Responsibilities

• Lead the development and execution of trial level site monitoring and oversight strategies, including monitoring risk assessments and site monitoring plans.
• Provide oversight of CRO delivered site management and monitoring activities to ensure quality, compliance, and timely study execution.
• Conduct trial level trend analysis, signal detection, risk identification, and issue management to support proactive decision making.
• Drive a risk based site monitoring approach and ensure monitoring activities align with study objectives and quality requirements.
• Collaborate with Clinical Trial Managers, Clinical Research Associates, and cross functional stakeholders to support study delivery against milestones and key performance indicators.
• Participate in the development and maintenance of trial level documents, amendments, training materials, and monitoring related procedures.
• Lead and contribute to trial oversight meetings, investigator meetings, and cross functional study discussions at global, regional, and local levels.
• Conduct site and monitoring oversight activities, implement follow up actions, and escalate issues when required.
• Serve as a subject matter expert on site management and monitoring, providing guidance and training to study teams.
• Support trial close out activities, including coordination of clinical data delivery and contribution to quality sections of clinical study reports.
• Facilitate timely responses to monitoring related questions from internal stakeholders, CRO partners, regulatory authorities, and ethics committees.
• Ensure inspection readiness and ongoing compliance with sponsor obligations, ICH GCP guidelines, SOPs, and regulatory requirements.

Candidate Profile

You’ll thrive in this role if you bring:

• Strong expertise in site monitoring, clinical trial oversight, and risk based quality management
• Experience working within global clinical development and regulated research environments
• The ability to influence and collaborate effectively across complex cross functional and matrix teams
• A patient focused mindset with a commitment to quality, compliance, and operational excellence
• Excellent communication, leadership, and stakeholder management skills
• The ability to identify risks, solve complex challenges, and drive successful study outcomes
• Strong organizational skills and attention to detail within fast paced global clinical programs

Required Qualifications

• University degree (Bachelor's or equivalent) in life sciences or a related field, or several years of equivalent professional education combined with significant experience in site monitoring and site management
• Several years of experience in site monitoring, site management, clinical trial operations, or a related clinical research field
• Demonstrated scientific and operational expertise across all aspects of clinical trial planning, site monitoring, and execution
• Strong knowledge of ICH GCP, regulatory requirements, sponsor oversight responsibilities, and clinical trial processes
• Proven ability to oversee complex clinical trials involving multiple sites, countries, vendors, and stakeholders
• Strong communication, organizational, training, and problem solving skills
• 
  

Key Responsibilities

• Lead the development and execution of trial level site monitoring and oversight strategies, including monitoring risk assessments and site monitoring plans.
• Provide oversight of CRO delivered site management and monitoring activities to ensure quality, compliance, and timely study execution.
• Conduct trial level trend analysis, signal detection, risk identification, and issue management to support proactive decision making.
• Drive a risk based site monitoring approach and ensure monitoring activities align with study objectives and quality requirements.
• Collaborate with Clinical Trial Managers, Clinical Research Associates, and cross functional stakeholders to support study delivery against milestones and key performance indicators.
• Participate in the development and maintenance of trial level documents, amendments, training materials, and monitoring related procedures.
• Lead and contribute to trial oversight meetings, investigator meetings, and cross functional study discussions at global, regional, and local levels.
• Conduct site and monitoring oversight activities, implement follow up actions, and escalate issues when required.
• Serve as a subject matter expert on site management and monitoring, providing guidance and training to study teams.
• Support trial close out activities, including coordination of clinical data delivery and contribution to quality sections of clinical study reports.
• Facilitate timely responses to monitoring related questions from internal stakeholders, CRO partners, regulatory authorities, and ethics committees.
• Ensure inspection readiness and ongoing compliance with sponsor obligations, ICH GCP guidelines, SOPs, and regulatory requirements.

Candidate Profile

You’ll thrive in this role if you bring:

• Strong expertise in site monitoring, clinical trial oversight, and risk based quality management
• Experience working within global clinical development and regulated research environments
• The ability to influence and collaborate effectively across complex cross functional and matrix teams
• A patient focused mindset with a commitment to quality, compliance, and operational excellence
• Excellent communication, leadership, and stakeholder management skills
• The ability to identify risks, solve complex challenges, and drive successful study outcomes
• Strong organizational skills and attention to detail within fast paced global clinical programs

Required Qualifications

• University degree (Bachelor's or equivalent) in life sciences or a related field, or several years of equivalent professional education combined with significant experience in site monitoring and site management
• Several years of experience in site monitoring, site management, clinical trial operations, or a related clinical research field
• Demonstrated scientific and operational expertise across all aspects of clinical trial planning, site monitoring, and execution
• Strong knowledge of ICH GCP, regulatory requirements, sponsor oversight responsibilities, and clinical trial processes
• Proven ability to oversee complex clinical trials involving multiple sites, countries, vendors, and stakeholders
• Strong communication, organizational, training, and problem solving skills
•