Information Security Solution Architect - Network Security (M/F/D) - Barcelona

Allianz Commercial; Barcelona; A distancia; EUR 65.000 - 95.000; Jornada completa

Descripción de la vacante

Allianz Commercial is seeking a Clinical Monitoring Analyst (Cluepoints) for a remote role. You will support the Centralized Monitoring Lead by developing CM elements such as QTL, KRIs, and data visualizations, and by refreshing the CM platform to identify signals.

You will also document CM platform specs and review study protocols. The role requires 2–3 years in pharmaceutical R&D, SAS (including macros), familiarity with Cluepoints, data management and biostatistics, and excellent English

Formación

• At least 2–3 years SAS experience including macro language.
• Experience with Cluepoints.
• Knowledge of data management and biostatistics in clinical research.
• Excellent verbal and written English communication.

Responsabilidades

• Set up/Program QTL, KRI and Data Quality Assessments per the study CMP.
• Refresh the Centralized Monitoring Platform at predefined frequency.
• Generate and maintain CM platform specifications document and file in eTMF.
• Review study protocol and understand data sources/transfer specs.
• Conduct peer-review of CM platform setup and document outcomes.

Conocimientos

SAS

Cluepoints

Data management

Biostatistics

Communication skills

Fluent English

Herramientas

Cluepoints

Descripción del empleo

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