Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Summarized Purpose:
Acts as a Subject Matter Expert (SME) and interdepartmental and client liaison for data analytics activities.
- Focuses on developing tools and processes to detect, investigate, diagnose, and mitigate clinical trial issues and risks.
- Leads one or more projects, including setting up functional plans, monitoring tools, and data review cycles.
- Provides expertise in centralized monitoring, site monitoring strategy, risk assessment, and clinical trial oversight.
- Ensures effective risk identification, trend analysis, and signal detection to support trial quality, patient safety, and data integrity.
Essential Functions and Other Job Information:
- Accountable for site monitoring strategy and oversight, including authoring risk assessments and monitoring plans.
- Ensure effective sponsor oversight, trend analysis, and signal detection to support trial quality and delivery.
- Provide site monitoring expertise to the trial team and lead the implementation of monitoring and oversight approaches.
- Oversee planning, execution, and issue management of site monitoring activities across all R/OPUs.
- Ensure compliance with protocols, ICH-GCP, regulatory requirements, and maintain inspection readiness.
- Safeguard patient safety, data integrity, and trial outcomes through effective monitoring oversight.
- Lead centralized monitoring activities, including the development of study-specific tools, monitoring plans, and data review processes.
- Perform complex data reviews, risk signal analysis, trend analysis, and root cause analysis to identify and mitigate potential risks.
- Monitor Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Risk-Based Quality Management (RBQM) activities.
- Manage review timelines, analysis assignments, project deliverables, and support budget management.
- Coordinate with internal teams, sponsors, and cross-functional stakeholders to ensure timely and high-quality deliverables.
- Prepare and deliver centralized monitoring reports and lead monitoring review meetings.
- Participate in cross-functional risk assessment meetings and contribute to overall risk planning and mitigation strategies.
- Develop and enhance monitoring tools, dashboards, and analytical processes to improve risk detection and operational efficiency.
- Provide training, mentoring, and guidance to junior team members.
- Act as a project lead, development specialist, or a combination of both, depending on project requirements.
Qualifications:
Education and Experience:
- Bachelor's degree in Life Sciences or a related field is mandatory.
- Minimum 8+ years of experience in Centralized Monitoring (CM), clinical monitoring, or related clinical trial activities.
- Hands-on experience in site monitoring strategy and oversight, including developing risk assessments and monitoring plans.
- Hands-on experience with centralized monitoring tools such as Spotfire, CluePoints, or equivalent platforms.
- Strong experience in Risk-Based Quality Management (RBQM), Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs).
- Practical experience in risk signal analysis, trend analysis, anomaly detection, and root cause analysis.
- Experience in clinical trial monitoring, site management, data management, biostatistics, or related clinical research activities.
- Experience leading centralized monitoring activities, managing review cycles, and coordinating with cross-functional teams.
- Strong understanding of clinical trial protocols, ICH-GCP guidelines, regulatory requirements, and global SOPs.
- Experience in sponsor oversight, clinical trial risk assessment, and risk mitigation.
- Experience managing complex clinical trials involving multiple sites, countries, vendors, and stakeholders.
- Equivalent professional education and directly relevant experience may be considered where applicable.
Strong Communication Skills:
- Demonstrates Accountability, Agility, and Intrapreneurship (AAI) in complex cross-functional and matrix team environments.
- Strong written and verbal communication skills in English.
- Ability to communicate effectively with internal teams, functional management, sponsors, and clients.
- Demonstrates active listening, cultural awareness, and strong stakeholder management skills.
- Ability to align business strategies, project objectives, and operational activities.
Scientific and Operational Expertise:
- Strong scientific, therapeutic, and operational knowledge of clinical trial planning and execution.
- Comprehensive understanding of site monitoring, centralized monitoring, and site management processes.
- Experience implementing risk-based monitoring strategies across clinical studies.
- Ability to interpret clinical trial protocols, monitoring plans, and study documentation.
- Strong understanding of clinical trial complexity involving protocols, patients, sites, countries, and vendors.
- Ability to identify, investigate, and mitigate clinical trial risks through data analytics and monitoring oversight.
Leadership and Influence:
- Demonstrates strong leadership skills in coordinating and overseeing cross-functional teams.
- Ability to independently lead projects and manage monitoring activities.
- Experience setting priorities, managing timelines, and ensuring high-quality deliverables.
- Ability to guide, mentor, and support junior team members.
- Strong decision-making and problem-solving skills in complex clinical trial environments.
- Ability to influence stakeholders and drive effective collaboration across teams.
Knowledge, Skills and Abilities:
- Strong knowledge of Centralized Monitoring (CM), Site Monitoring, and Risk-Based Quality Management (RBQM).
- Hands-on experience with Spotfire, CluePoints, or similar centralized monitoring tools.
- Strong understanding of KRIs, QTLs, risk signal analysis, trend analysis, and anomaly detection.
- Ability to perform complex data reviews, root cause analyses, and risk assessments.
- Strong analytical, numerical, and problem-solving skills with attention to detail.
- Ability to identify trends and potential risks using clinical trial data and electronic study systems.
- Comprehensive understanding of clinical trial protocols, centralized monitoring plans, and functional study documentation.
- Ability to apply regulatory guidelines, global SOPs, and client requirements.
- Strong organizational and project management skills, including planning, prioritization, and workload management.
- Ability to independently manage multiple projects and coordinate activities across teams.
- Strong stakeholder management and cross-functional collaboration skills.
- Ability to maintain confidentiality of clinical trial data and client information.
- Proven flexibility, adaptability, and accountability in changing project environments.
- Strong computer skills, including proficiency in Microsoft Office (Word, Excel, and PowerPoint).
- Ability to learn and effectively utilize clinical trial monitoring and data analytics systems.
- Ability to serve as a Subject Matter Expert (SME) and lead cross-functional projects.