We invite you to become a key player in our team as a Clinical Trials Data Analytics Manager! This role is essential for enhancing the performance of global clinical trials through insightful data analysis and actionable insights.
In this exciting position, you will oversee the configuration of studies within our Risk-Based Quality Management (RBQM) platform. You will ensure timely data updates, address any technical issues, and apply your programming expertise for advanced data analysis and reporting. You'll have the opportunity to present Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs), analyze operational data and trends, and deliver valuable insights to support informed decision-making.
As a vital member of our Central Monitoring team, you'll manage multiple studies within specialized therapy areas, spearhead process improvement initiatives, and enhance our central monitoring capabilities. Collaboration with cross-functional teams and industry partners will be crucial while you leverage your technical skills and problem-solving abilities in a dynamic environment.
Key Responsibilities:
- Act as a subject matter expert in configuring and implementing Central Monitoring RBQM systems across diverse studies.
- Maintain the Central Monitoring Key Risk Indicators and Quality Tolerance Limit Libraries to ensure adherence to regulatory standards.
- Work closely with stakeholders to develop specifications for Central Monitoring within the RBQM system.
- Provide operational guidance and expertise on Central Monitoring issues related to RBQM systems.
- Support study monitors by conducting comprehensive central monitoring reviews.
- Contribute to efforts aimed at standardizing technologies, processes, and training materials to improve Central Monitoring and RBQM performance.
- Represent Central Monitoring in organization-wide process improvement initiatives.
- This role may involve up to 25% travel.
Qualifications:
- A minimum of 4 years of relevant experience in the biotechnology or pharmaceutical industry.
- Preferred background in Central Monitoring, site monitoring, or data management.
- At least 2 years of hands-on 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 for sophisticated data analysis and automation tasks.
- Solid understanding of the clinical drug development process, including ICH, GCP guidelines, and regulatory standards.
- Strong analytical skills in mathematics, statistical methodologies, and data analytics, particularly in interpreting KRIs and KPIs.
- Experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures.
- Advanced skills in Microsoft Excel for data manipulation and reporting, alongside 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 that encourages applicants from diverse backgrounds to create an inclusive work environment.