Central Monitoring Manager

Remote, Madrid +1·Full-time·Added 11 days ago

PSI CRO

5 open roles

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Overview

Job details

Full-time hours
Per the ad.
Fully remote
Per the ad.

Requirements

Have the right to work in Spain
PSI CRO doesn't mention sponsorship in the ad.
Work in English
English is required, per the ad.
University degree
“College/University degree or an equivalent combination of education, training and experience” — per the ad.

Pay & benefits

What you'll get

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.

The role

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.

What you'll do

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 the process and functions in clinical trials, ability to understand the protocol and study associated risks
Full working proficiency in English (Spanish proficiency is a plus)
Proficiency in MS Office applications, Excel skills
Please submit your CV/resume in English only

About PSI CRO

PSI CRO is a global contract research organization (CRO) providing clinical development services to the pharmaceutical, biotechnology, and medical device industries. With over 25 years of experience, the company manages clinical trials across all phases, offering services from project management and biostatistics to data management and medical writing. PSI CRO operates in more than 30 countries and employs over 2,500 professionals, making it a significant player in the clinical research outsourcing sector.

In Spain, PSI CRO has established a strong presence, with offices in Barcelona and Madrid, supporting its global operations and serving as a hub for clinical trial management in Southern Europe. The company is known for its collaborative, employee-focused culture, often ranking as a top employer in the CRO industry. For international professionals, PSI CRO offers opportunities to work on global clinical trials, with a multicultural environment and a commitment to professional development, making it an attractive option for those looking to advance their careers in clinical research while living in Spain.

Industry: Clinical Research
Founded: 1995
Employees: 1,000–5,000
Headquarters: Princeton, USA
In Spain: Barcelona, Madrid
Website: psi-cro.com

Good to know if you are moving

PSI CRO has offices in Barcelona and Madrid, offering opportunities to work in two of Spain's most vibrant cities.
The company operates in over 30 countries, providing international career growth and the chance to work on global clinical trials.
PSI CRO is consistently recognized as a top employer in the CRO industry, with a strong focus on employee satisfaction and work-life balance.
Spain is a key hub for PSI CRO's Southern European operations, with a multicultural team and English as the working language.
The company offers relocation support for international hires, including assistance with visas and settling in Spain.

In their own words

About the company & team

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.

All open roles at PSI CRO