Real-Time Embedded Requirements & Test Engineer (Hybrid)

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

Clinical Monitoring Analyst (Cluepoints) - Remote

London, United Kingdom
Budapest, Hungary
Reading, Berkshire, United Kingdom
Bloemfontein, South Africa
Dublin, Ireland
Centurion, South Africa
Barcelona, Spain
Sofia, Bulgaria
Madrid, Spain
Full time
R

• Supports the Centralized Monitoring Lead (CML) in the development of the fit-for purpose CM strategy by contributing to the identification of the relevant CM elements to be implemented for the study (Quality Tolerance Limits (QTL), Key Risk Indicators, data visualizations and Data Quality Assessments)
• Setup/Program QTL, KRI and Data Quality Assessments according to the study CMP
• Refresh the Centralized Monitoring Platform at predefined frequency to enable signal identification
• Generate and maintain the Centralized Monitoring Platform specifications document and file it in eTMF
• Review and understanding of protocol is key
• Understand the data sources for the study, the data transfer specifications and the data structure
• Execute and document peer-review of CM platform setup done by other CMA colleagues

Experience

• At least 3 years relevant experience in the area of pharmaceutical research and development or related field preferably in centralized Monitoring, data management, and/or biostatistics
• 2-3 years SAS experience including macro language
• Knowledge/ experience working on Cluepoints
• Ability to work in an autonomous way and engage with relevant stakeholders to execute activities related to study level centralized monitoring process.
• Ability to understand basic statistical analysis concepts and to interpret their outcome.
• Ability to maintain confidentiality of data and information during interactions with staff at all levels
• Ability to work with limited close supervision.
• Demonstrated communication, interpersonal, organizational and problem-solving skills
• High levels of initiative, drive and commitment.
• Prior experience in a Data Management related field is required
• Experience with relational databases, preferably Clinical Data Management and EDC Systems
• Experience communicating with all levels of personnel and participating in collaborative work team (locally and globally).
• Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.
• Excellent command, both verbal and written, of English

This role is not eligible for UK visa sponsorship

EEO Minorities/Females/Protected Veterans/Disabled