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- Aufgaben: Lead risk-based monitoring for clinical studies, ensuring patient safety and data integrity.
- Arbeitgeber: PSI is a top-tier Contract Research Organization with nearly 30 years of experience in the industry.
- Mitarbeitervorteile: Enjoy flexible working conditions, competitive salary, and a strong mentorship program.
- Andere Informationen: This role offers a unique blend of teamwork and independence in a rapidly evolving industry.
- Warum dieser Job: Join a booming field, gain global insights, and work on innovative risk-based models.
- Gewünschte Qualifikationen: College degree required; experience in clinical study management and strong communication skills essential.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
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 theprocessand functions in clinical trials, ability to understand the protocol and study associated risks
- Full working proficiency in English (German proficiency is a plus)
- Proficiency in MS Office applications,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 modelsand 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.
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Central Monitoring Manager Arbeitgeber: PSI CRO
Kontaktperson:
PSI CRO HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Central Monitoring Manager
✨Tip Number 1
Familiarize yourself with the latest trends in risk-based monitoring (RBM) within clinical trials. Understanding the nuances of RBM will not only help you during interviews but also demonstrate your commitment to staying updated in this rapidly evolving field.
✨Tip Number 2
Network with professionals in the clinical research industry, especially those who have experience in centralized monitoring. Engaging in discussions and attending relevant webinars or conferences can provide valuable insights and connections that may benefit your application.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences where you successfully led risk management initiatives or dealt with complex data analysis. Being able to articulate these experiences clearly will showcase your leadership and analytical skills effectively.
✨Tip Number 4
Research PSI's company culture and values thoroughly. Tailoring your conversations and questions during the interview to align with their focus on quality and innovation will demonstrate your genuine interest in becoming a part of their team.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Central Monitoring Manager
Tipps für deine Bewerbung 🫡
Understand the Role: Take the time to thoroughly read the job description for the Central Monitoring Manager position at PSI. Understand the key responsibilities and qualifications required, as this will help you tailor your application effectively.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in clinical study management and centralized monitoring. Provide specific examples of how you've led risk management initiatives or worked with complex data to demonstrate your suitability for the role.
Showcase Communication Skills: Since strong communication and presentation skills are essential for this position, make sure to highlight any relevant experiences where you successfully communicated complex information to diverse audiences. This could include presentations, reports, or team collaborations.
Tailor Your Application: Customize your cover letter to reflect your understanding of PSI's focus on quality and innovation. Mention how your values align with theirs and express your enthusiasm for contributing to their mission in the clinical research field.
Wie du dich auf ein Vorstellungsgespräch bei PSI CRO vorbereitest
✨Understand Risk-Based Monitoring
Make sure you have a solid grasp of risk-based monitoring concepts. Be prepared to discuss how you would implement these strategies in clinical studies, as this is a key focus for the role.
✨Showcase Your Communication Skills
Since strong communication and presentation skills are essential, practice articulating your thoughts clearly. Prepare to present hypothetical analysis results and manage issues in a cross-functional environment during the interview.
✨Demonstrate Leadership Experience
Highlight your previous leadership roles and experiences. Be ready to discuss how you've led teams or projects, especially in clinical settings, and how you can guide others in implementing risk management strategies.
✨Prepare for Data Analysis Questions
Expect questions related to data analysis and critical thinking. Brush up on your analytical skills and be prepared to provide insights into how you would handle complex data and risk reports.