Clinical Monitoring Analyst (CMA)

Nanosep AB; London; Remote; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Centralized Monitoring Analyst to play a pivotal role in enhancing clinical research processes. This position involves developing monitoring strategies, programming key metrics, and collaborating with stakeholders to ensure data quality and confidentiality. The ideal candidate will have a strong background in pharmaceutical research, particularly in centralized monitoring and data management. If you are self-motivated, possess excellent communication skills, and are eager to contribute to improving patient outcomes, this opportunity is perfect for you. Join a team dedicated to innovation and excellence in healthcare.

Qualifications

• Minimum of 3 years experience in pharmaceutical research or related fields.
• 2-3 years of SAS experience, including macro language.
• Prior experience in Data Management is required.

Responsibilities

• Support the Centralized Monitoring Lead in developing CM strategies.
• Set up and program QTLs, KRIs, and Data Quality Assessments.
• Generate and maintain the Centralized Monitoring Platform specifications.

Skills

SAS Programming

Data Management

Biostatistics

Statistical Analysis

Communication Skills

Problem-Solving Skills

Education

Degree in Life Sciences or Related Field

Tools

eTMF

EDC Systems

Relational Databases

Job description

Job Title: Centralized Monitoring Analyst (CMA) at IQVIA

This unique role within IQVIA is for a Lead Programmer on Cluepoints, called a Centralized Monitoring Analyst (CMA), requiring strong communication and organizational skills. Experience with SAS programming is necessary. The role can be based remotely in various European countries or South Africa.

This position is part of a sponsor-dedicated project, working directly with the client to manage deliverables.

Main Responsibilities:

1. Support the Centralized Monitoring Lead (CML) in developing a fit-for-purpose CM strategy, including identifying relevant CM elements such as QTLs, KRIs, data visualizations, and Data Quality Assessments.
2. Set up and program QTLs, KRIs, and Data Quality Assessments according to the study's Centralized Monitoring Plan (CMP).
3. Refresh the Centralized Monitoring Platform regularly to enable signal detection.
4. Generate and maintain the Centralized Monitoring Platform specifications document and file it in eTMF.
5. Review and understand study protocols thoroughly.
6. Understand data sources, transfer specifications, and data structure for the study.
7. Perform peer-reviews of CM platform setups conducted by colleagues.

Experience and Skills:

• Minimum of 3 years relevant experience in pharmaceutical research, development, or related fields, preferably in centralized monitoring, data management, or biostatistics.
• 2-3 years of SAS experience, including macro language, is preferred.
• Ability to work autonomously and engage with stakeholders to execute centralized monitoring activities.
• Basic understanding of statistical analysis concepts and interpretation of outcomes.
• Ability to maintain data confidentiality.
• Self-motivated with minimal supervision.
• Strong communication, interpersonal, organizational, and problem-solving skills.
• High initiative, drive, and commitment.
• Prior experience in Data Management is required.
• Experience with relational databases, Clinical Data Management, and EDC Systems.
• Experience communicating across all organizational levels and working in collaborative teams globally.
• Knowledge of federal regulations, GCP, and Good Clinical Data Management Practices.
• Excellent command of English, both verbal and written.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We aim to accelerate the development and commercialization of medical treatments to improve patient outcomes worldwide. Learn more at https://jobs.iqvia.com.

We value diverse talent with curious minds and a commitment to innovation. Everyone at IQVIA contributes to our mission of improving lives globally. Thank you for your interest in growing your career with us.

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