Central Monitoring Manager
Company
PSI CRO
Location
Other US Location
Type
Full Time
Job Description
Company Description
PSI is a leading Contract Research Organization with almost 30 years 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.
Job Description
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
Qualifications
- 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 theĀ processĀ and functions in clinical trials, ability to understand the protocol and study associated risks
- Full working proficiency in English and German
- Proficiency in MS Office applications,Ā Excel skills
Additional Information
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 modelsĀ and get a global helicopter view on each project.
Our extensive onboarding and mentorship program will prepare you to fulfil your tasks with the highest standards, offering you:
- Excellent and flexible working conditions.
- A unique combination of team collaboration and independent work.
- Competitive salary and benefits package.
If you'd like to hear more about PSI, our organic growth and company culture, and learn more about the studies that we run and our high repeat and referral business rates, please apply for this vacancy.
Date Posted
01/21/2025
Views
0
Similar Jobs
Senior Engineering Manager, Micros Foundations - Atlassian
Views in the last 30 days - 0
Atlassian is seeking a Senior Engineering Manager to lead a team of Backend Software Engineers The role involves guiding technical decisions prioritiz...
View DetailsSenior Professional Services Consultant - Cloudflare
Views in the last 30 days - 0
The role of a Professional Services Consultant for Application Security and Performance at Cloudflare involves providing advisory and handson keyboard...
View DetailsSenior Product Analyst - FinCrime Platform - WISE
Views in the last 30 days - 0
Wise is seeking a Senior Product Analyst for its FinCrime Platform The role involves driving analytics efforts in the Financial Crime Platform product...
View DetailsBecario GMP - Cencora
Views in the last 30 days - 0
Cencora is seeking a dedicated professional to join their innovative team aiming to improve lives of people and animals The role involves evaluating p...
View DetailsSenior Pricing Analyst - Cencora
Views in the last 30 days - 0
Cencora formerly known as AmerisourceBergen is a leading global pharmaceutical solutions organization They are currently experiencing rapid growth in ...
View DetailsTeam Lead, Expansion Account Executive - Personio
Views in the last 30 days - 0
Personio a human resources platform is seeking a Team Lead Expansion Account Executive with 5 years of experience in B2B software sales The role invol...
View Details