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 experienceClinical Study Lead / Manager experienceStrong communication & presentation skills are essentialLeadership and ability to work independently are essentialCentralized Monitoring experience is a plusCritical thinking and analytical skillsAbility to work with complex data and provide insight into risk reports and trendsAbility to adapt to changing circumstances and learn quicklyKnowledge of the process and functions in clinical trials ability to understand the protocol and study associated risksFull working proficiency in EnglishProficiency in MS Office applications Excel skillsAdditional 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 models and get a global helicopter view on each project.
Remote Work : No
Employment Type : Full-time
Key Skills
Cruise,Dcom,HVAC Design,Arabic,Asic
Experience : years
Vacancy : 1