Job Details

The Manager of Data Analysis plays a vital role in enhancing centralized monitoring activities for global clinical trials. This position focuses on the effective configuration, execution, and maintenance of Risk-Based Quality Management (RBQM) systems. If you are passionate about optimizing clinical trial performance through data insights and analysis, this could be the perfect opportunity for you!

In this role, you will be responsible for configuring studies within an RBQM platform, performing regular data updates, troubleshooting execution errors, and leveraging your programming expertise for advanced data analyses and reporting. You will interpret and present Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs), conduct reviews of operational data and trends, and provide actionable insights for informed decision-making.

As part of the Central Monitoring team, you will oversee multiple studies within a specific therapy area, lead process improvement initiatives, and innovate central monitoring capabilities in collaboration with cross-functional teams and industry partners. Your technical skills, analytical problem-solving acumen, and effective communication will be key to thriving in this dynamic, fast-paced environment.

Key Responsibilities:

• Serve as a subject matter expert for the configuration and implementation of Central Monitoring RBQM systems across various studies.

• Maintain and manage the Central Monitoring Key Risk Indicators and Quality Tolerance Limit Libraries to ensure consistency and compliance with regulatory standards.

• Collaborate with various stakeholders to develop configuration specifications for Central Monitoring within the RBQM system.

• Provide operational expertise and guidance as a resource for Central Monitoring issues related to RBQM systems.

• Conduct central monitoring reviews in support of study monitors.

• Engage in standardization efforts for technologies, systems, processes, and training materials that enhance Central Monitoring and RBQM.

• Represent Central Monitoring in process improvement initiatives across the organization.

• This position may require up to 25% travel.

Qualifications:

• A minimum of 4 years of relevant experience in the biotechnology or pharmaceutical industry.

• Experience in Central Monitoring, site monitoring, or data management is preferred.

• At least 2 years of direct experience with RBQM systems.

• Technical expertise in database design, system configuration, and report development, with experience managing RBQM systems or similar platforms.

• Proficiency in programming languages such as Python, R, SQL, or SAS to write scripts for data analysis and automation.

• Strong understanding of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements.

• Aptitude in mathematical concepts, statistical methodologies, and data analytics, focusing on KRIs and KPIs interpretation.

• Experience with clinical databases, electronic data capture systems, quality control processes, and audit procedures.

• Advanced skills in Microsoft Excel for data manipulation and reporting, along with proficiency in other Microsoft Office applications.

• Preferred: Familiarity with CluePoints or similar centralized monitoring and RBQM solutions.

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EEO Disclaimer

Parexel is an equal opportunity employer and welcomes applicants from diverse backgrounds to ensure an inclusive work environment.