PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.
At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.
We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.
Company Description
PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.
At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.
We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.
Job Description
Clincial Data Manager plays a critical role in the clinical research project. If you are detail-oriented and committed to quality, able to work with large volume of clinical or medical data, you might be the professional we are looking for.
**Please submit your CV in English**
**Based in Brazil**
**Responsibilities will include:**
* Track database set-up, testing, maintenance and data entry
* Communicate with clients, project teams and vendors on data management matters
* Review study documents, design and develop project specific guidelines and instructions
* Design eCRF, Data Management and Data Validation Plans and test EDC databases
* Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation
* Code medical data
* Track and report metrics leading to database lock
* Coordinate the processing, dispatch and archiving of CRFs/queries
* Maintain Clinical Data Management working files
* Perform database QC checks, prepare and attend audits
* Train site staff and project teams on CRF completion and data management topics
Qualifications
* College/University degree (Life Science, Pharmacy degree is a plus)
* Demonstrated experience of managing clinical or medical data
* Full working proficiency in English
* Experience with Clinical Data Management systems (e.g. Medidata Rave, Oracle InForm)
* Proficiency in MS Office applications
* Organisational and time management skills
* Ability to work independently and multi-task
Additional Information
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
