24 Oct
|
Parexel
|
Secunderabad
24 Oct
Parexel
Secunderabad
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 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.
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.
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.
Present findings to clinical study teams, support root cause analysis, and provide recommendations for follow-up actions to address identified risks.
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.
Strengths in analytical problem-solving, critical thinking, and data interpretation
Experience working in clinical research, healthcare, or a regulated setting
Comfort working with clinical databases, electronic data capture systems, and data analytics tools
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
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
Join us and be part of a team where your contributions help shape the future of clinical research.
📌 Development and Data Analyst (Secunderabad)
🏢 Parexel
📍 Secunderabad