Join our team as the Manager of Data Analysis, where you will oversee centralized monitoring activities for intricate global clinical trials. You will be pivotal in ensuring the successful configuration, execution, and maintenance of Risk-Based Quality Management (RBQM) systems. This position involves configuring studies within our RBQM platform, performing data refreshes, troubleshooting issues, and applying your programming skills for advanced data analyses, automation, and reporting.
As a vital part of the Central Monitoring team, you will interpret and present Key Risk Indicator (KRI) and Key Performance Indicator (KPI) data, while also thoroughly reviewing operational data, trends, and issues. Your expertise in programming languages such as R, SQL, or SAS will be crucial for creating custom analyses and automating workflows, allowing us to present actionable insights that enhance decision-making and trial performance.
In this role, you will manage multiple studies within a designated therapy area, lead process improvement initiatives, and innovate central monitoring capabilities in collaboration with cross-functional teams and industry partners. The role demands a blend of technical proficiency, analytical problem-solving skills, and excellent communication to thrive in a dynamic environment.
Key Responsibilities:
- Act as a subject matter expert in configuring, implementing, and executing the Central Monitoring RBQM system across various studies.
- Maintain Central Monitoring Key Risk Indicators and Quality Tolerance Limit Libraries to ensure consistent standards and regulatory compliance.
- Collaborate with functional and cross-functional stakeholders to develop configuration specifications for Central Monitoring in the RBQM system.
- Provide operational expertise, training, and act as a point of escalation for Central Monitoring issues related to the RBQM system.
- Conduct thorough central monitoring reviews supporting the study central monitor.
- Engage in continuous improvements to standardize technologies, systems, processes, and training materials that support Central Monitoring and RBQM.
- Represent Central Monitoring in initiatives focused on process improvement.
- This role may require up to 25% travel.
Qualifications:
- A minimum of 4 years of experience in the biotechnology or pharmaceutical industry.
- Experience in Central Monitoring, site monitoring, or data management is a plus.
- 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.
- Proficient in programming languages such as Python, R, SQL, or SAS, capable of developing scripts for data analysis, automation, and system integration.
- Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements.
- Aptitude for mathematical concepts, statistical methodologies, and data analytics, focusing on interpreting KRIs and KPIs.
- Experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures.
- Proficient in Microsoft Office applications, specifically advanced skills in Excel for data manipulation and reporting.
- Preferred: Familiarity with CluePoints or similar centralized monitoring and RBQM solutions.
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.