At a Glance
- Tasks: Support Centralized Monitoring processes and collaborate with clients on project deliveries.
- Company: Join a leading pharmaceutical research organisation focused on innovation.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Other info: Autonomous role with global collaboration and excellent career advancement opportunities.
- Why this job: Make a real impact in clinical research while developing your skills in a dynamic environment.
- Qualifications: 3+ years in pharmaceutical research, SAS programming experience, and strong communication skills.
The predicted salary is between 63000 - 77000 £ per year.
This unique role within IQVIA lends itself to a Lead programmer on Cluepoints called Centralized Monitoring Analyst (CMA) with strong communication and organisation skills. Having experience with SAS programming is necessary. This role is part of a sponsor dedicated project where you will be working with the client directly to manage deliveries. The CMA contributes to the execution of the Centralized Monitoring process by performing the setup, programming and refresh(es) of the Centralized Monitoring platform, according to the study-specific Centralized Monitoring Plan (CMP).
Main responsibilities include:
- 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
Clinical Monitoring Analyst (Cluepoints) - Remote employer: IQVIA LLC
At IQVIA, we pride ourselves on being an exceptional employer, particularly for those in the field of Pharmaceutical Development. Our Cambridge location fosters a collaborative and innovative work culture, where you will have the opportunity to influence scientific direction, mentor junior scientists, and engage directly with clients. With a strong focus on employee growth and the integration of cutting-edge AI-enabled approaches, we are committed to supporting your professional development while making a meaningful impact in the pharmaceutical industry.
