Description review
Central Monitoring Manager
PSI CRO · Hungary · back to the listing
HR standards
42/100
poor
Title ↔ description
70/100
solid
Reads as
Unclear
no confident match
What this role officially is
project manager — ESCO, the EU occupation classification
Project managers ensure that a project is completed on time, within budget, and that its objectives are met. They oversee the project, manage the team, ensure the most efficient resources are used and ensure that all parties involved are satisfied.
Also known as: project coordinator, project leader, special project manager, project expediter, senior project manager, project director
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What the listing never says
- 21 bullet points. Long requirement lists deter qualified candidates, who read them as hard gates. Scope clarity
- No section describes what the person would actually do. Scope clarity
- No pay range published. Candidates cannot tell whether applying is worth their time. Pay transparency
- No location or timezone policy stated, so a candidate cannot tell where they may work from. Scope clarity
The listing, marked up
With the industry moving forward, the central monitoring function has become a top priority at PSI. We are looking for a person, who would lead the risk-based monitoring approach implementation on the clinical study and program level to ensure patient safety and data integrity.
You will:
• Lead and facilitate initial and ongoing study Risk Management
• Participate in selection and setup of the RBM platform
• Perform Centralized Monitoring for a study including review of Key Risk Indicators, Statistical Analyses and Quality Tolerance Limits
• Present Centralized Monitoring analysis results to study teams and clients and manage issues in cross-functional environment
• Develop and review study-specific Plans
• Set up and manage targeted SDV and monitoring strategy for a study
• Set up and manage Central Data Review activities in a study
• Contribute to Proposals and bid defense meetings with information about Risk Based Monitoring services
• Communicate study challenges to Clinical Data Science group and work out data-driven solutions
• College/University degree or an equivalent combination of education, training and experience
• Clinical study lead/ manager experience
• Strong communication & presentation skills are essential
• Leadership and ability to work independently are essential
• Centralized Monitoring experience is a plus
• Critical thinking and analytical skills
• Ability to work with complex data and provide insight into risk reports and trends
• Ability to adapt to changing circumstances and learn quickly
• Knowledge of the process and functions in clinical trials, ability to understand the protocol and study associated risks
• Full working proficiency in English
• Proficiency in MS Office applications, Excel skills
• Applications must be submitted in English
This role is not only important for every CRO, but it is booming now. This is an opportunity to work on a frontline of the industry, set the grounds for risk-based models and get a global helicopter view on each project.
PSI is a leading Contract Research Organization with more than 25 years1 on the market, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Originally posted on Himalayas
You will:
• Lead and facilitate initial and ongoing study Risk Management
• Participate in selection and setup of the RBM platform
• Perform Centralized Monitoring for a study including review of Key Risk Indicators, Statistical Analyses and Quality Tolerance Limits
• Present Centralized Monitoring analysis results to study teams and clients and manage issues in cross-functional environment
• Develop and review study-specific Plans
• Set up and manage targeted SDV and monitoring strategy for a study
• Set up and manage Central Data Review activities in a study
• Contribute to Proposals and bid defense meetings with information about Risk Based Monitoring services
• Communicate study challenges to Clinical Data Science group and work out data-driven solutions
• College/University degree or an equivalent combination of education, training and experience
• Clinical study lead/ manager experience
• Strong communication & presentation skills are essential
• Leadership and ability to work independently are essential
• Centralized Monitoring experience is a plus
• Critical thinking and analytical skills
• Ability to work with complex data and provide insight into risk reports and trends
• Ability to adapt to changing circumstances and learn quickly
• Knowledge of the process and functions in clinical trials, ability to understand the protocol and study associated risks
• Full working proficiency in English
• Proficiency in MS Office applications, Excel skills
• Applications must be submitted in English
This role is not only important for every CRO, but it is booming now. This is an opportunity to work on a frontline of the industry, set the grounds for risk-based models and get a global helicopter view on each project.
PSI is a leading Contract Research Organization with more than 25 years1 on the market, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Originally posted on Himalayas