About Parexel
Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.
About the Role
We are seeking a Data Surveillance Analyst to join our team. As a Data Surveillance Analyst, you will support clinical research activities that advance new treatments for patients. This position plays a key role in study execution, patient safety oversight, regulatory compliance, and clinical data accuracy. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from planning through closeout.
Responsibilities include leading centralized monitoring activities for global and complex trials, analyzing key risk and operational performance data, and presenting findings to clinical study teams. With diverse teams and continuous learning opportunities, the Data Surveillance Analyst can explore career paths and expand skills across clinical research and risk-based quality management.
Key Responsibilities
- Collaborate on Study Quality Risk Assessment: Participate in the development and refinement of the Study Quality Risk Assessment and Control Tracker (QRACT) to identify and manage study risks.
- Develop and Author the Central Monitoring Plan: Lead the creation of the Central Monitoring Plan, ensuring alignment with study-specific needs and Risk Based Quality Management (RBQM) methodologies.
- Oversee Central Monitoring Execution: Work with data analysts to configure, implement, and execute the Central Monitoring RBQM system across assigned studies, ensuring effective signal detection.
- Analyze and Interpret Data Trends: Conduct study-level Central Monitoring Reviews using data analysis tools, interpret KRIs/KPIs, and assess trends to identify areas requiring intervention.
- Facilitate Study Team Decisions: Present findings to clinical study teams, support root cause analysis, and provide recommendations for follow-up actions to address identified risks.
- Document and Track Actions: Document outputs from Central Monitoring Review meetings, track decisions, and ensure timely closure of actions.
- Act as Central Monitoring Subject Matter Expert: Represent Central Monitoring as a subject matter expert during audits, inspections, and within study teams on RBQM processes.
- Provide Oversight of CRO Activities: Partner with outsourcing management to align monitoring strategies and ensure CRO partners execute Central Monitoring activities according to agreed standards.
- Drive Process Improvements: Evaluate the effectiveness of Central Monitoring processes, identify areas for improvement, and recommend enhancements to tools, metrics, and methodologies.
- Represent Central Monitoring in Initiatives: Represent the function in cross-functional process improvement initiatives and assess emerging technologies to enhance Central Monitoring capabilities.
You'll thrive in this role if you bring:
- Strengths in analytical problem-solving, critical thinking, and data interpretation
- Experience working in clinical research, healthcare, or a regulated environment
- The ability to collaborate across teams and communicate clearly
- A patient-focused mindset and strong attention to detail
- Comfort working with clinical databases, electronic data capture systems, and data analytics tools
Required Qualifications
- Bachelor's Degree or equivalent experience
- At least 7 years of relevant experience in the biotechnology/pharmaceutical industry, with a minimum of 1 year with direct Central Monitoring experience
- Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes
- Experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures
- Strong communication, organization, and problem-solving skills
Preferred Qualifications
- Master's Degree in a relevant field
- Experience in site monitoring or data management
- Familiarity with CluePoints or similar centralized monitoring RBQM systems
- Advanced proficiency in Microsoft Excel for data manipulation and reporting
If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!
We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.