Remote Centralized Monitoring Analyst

Prestwick Aerosystems; Getafe; Remote; EUR 55,000 - 75,000; Full time

Job summary

Cluepoints is seeking a Clinical Monitoring Analyst to support the Centralized Monitoring Lead in developing monitoring strategies and implementing QTL, KRIs and data quality assessments. The role requires SAS expertise and familiarity with Cluepoints, along with strong data management skills.

You will work autonomously with stakeholders, understand data sources, and contribute to CM platform setup and quality documentation while ensuring regulatory compliance and high-quality communication in

Qualifications

• 3+ years in pharmaceutical R&D, centralized monitoring or related field
• 2-3 years SAS experience including macro language
• Knowledge/experience with Cluepoints
• Autonomous, able to engage stakeholders
• Understand basic statistical concepts and interpretation
• Maintain data confidentiality across levels
• Experience with relational databases and EDC systems
• Strong communication and problem-solving skills
• Advanced knowledge of GCP, GCDMP and regulatory requirements
• Excellent command of English

Responsibilities

• Support Centralized Monitoring Lead in developing CM strategy
• Set up QTL, KRI and Data Quality Assessments per CMP
• Refresh CM Platform at predefined frequency for signal detection
• Maintain CM Platform specifications document in eTMF
• Review study protocol and data sources
• Document peer-review of CM platform setups

Skills

SAS

Cluepoints

Data management

Biostatistics

Communication skills

Interpersonal skills

Problem-solving

Regulatory knowledge

Tools

Cluepoints

EDC Systems

Job description

Cluepoints is seeking a Clinical Monitoring Analyst to support the Centralized Monitoring Lead in developing monitoring strategies and implementing QTL, KRIs and data quality assessments. The role requires SAS expertise and familiarity with Cluepoints, along with strong data management skills.

You will work autonomously with stakeholders, understand data sources, and contribute to CM platform setup and quality documentation while ensuring regulatory compliance and high-quality communication in