Central Monitoring Manager

🕒 April 25

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

Healthcare Insurance • Pharmaceuticals • Science

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• Employees can work remotely