Clinical Data Reviewer
Psi Cro
São Paulo
Additionalinformation
Additional Information
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
Companydescription
Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Jobdescription
Job Description
You will join a widespread, yet closely-knit team with the same mentality and desire to develop smart and intelligent approach to project monitoring. You will help to shape the future of effective risk-based monitoring at PSI and ensure higher quality of study data. You will spend time monitoring study data remotely, identifying errors and issues with site performance.
You will:
- Review clinical data remotely and identify errors, systemic issues and trends related to data integrity, participant safety and site performance
- Generate, follow up and resolve data queries and site issues, and identify potential protocol deviations
- Develop and maintain study-specific Central Data Review tools, templates and tracking materials
- Support the setup and management of risk-based and central monitoring tools and activities
- Assist with central monitoring signal review, root cause investigation and follow-up
- Support the Central Monitoring Manager with study data, documents and reports
- Contribute to inspection readiness, including eTMF QC and study archive activities
Qualifications
- Bachelor’s degree
- At least 1 year of experience in the Clinical Research Industry
- Clinical Monitoring experience is an advantage
- English proficiency at CEFR B2 level or above
- Proficiency in MS Office applications
- Analytical mindset and attention to detail
- Ability to learn, plan and work effectively in a dynamic team environment
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