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Skills: Clinical Data Management, eCRF Design, EDC Databases, Data Validation, Medical Coding
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Full-time
bachelor degree
Posted 36d ago
~40 hrs/week
Responsibilities
The Clinical Data Manager is responsible for the setup, testing, and maintenance of clinical databases and the design of eCRFs and validation plans. They coordinate data entry, perform QC checks, and manage communication with clients and vendors to ensure database lock.
Requirements
Candidates must hold a university degree, preferably in Life Sciences or Pharmacy, and have demonstrated experience managing clinical or medical data. Proficiency in English and experience with systems like Medidata Rave or Oracle InForm are required.
Full job description
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.
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
Offices: Baarerstrasse 113a, Zug, 6300, CH
Number One Patient Enrollment CROClinical ResearchClinical TrialsOncologyHematologyMultiple SclerosisInfectious DiseasesPatient EnrollmentPhase 2 Phase 3