Clinical Data Manager

ProClinical Limited
Paris Island Little
11 Jan 2018
10 Feb 2018
Contract Type
Full Time
ProClinical is seeking a Clinical Data Manager for a global pharmaceutical company, this role will be based permanently in Paris.

Job Responsibilties:

* Write the data management plan and program / validate the consistency tests in Capture system and SAS
* Coordinate the data management activities with the project team
* Design eCRF in accordance with the study protocol
* Review queries generated before sending to investigators
* Ensure reconciliation of SAEs
* Carry out data extraction for statisticians
* Provide update reports to study teams on regular basis
* Work collaboratively with the Clinical Operations Team and Project Management
* Facilitate the query resolution process
* Ability to handle multiple projects at the same time
* Ability to handle large projects (sample size 1000+)
* Ability to define performance metrics.

Skills and Requirements:

* At least eight years of hands on experience in clinical data management for Phase 2/3 clinical studies.
* Very good working knowledge of EDC systems
* Preliminary knowledge of Oncology Therapeutic area
* Decent Working Knowledge of SAS
* Good Understanding of CDASH Concepts
* Decent understanding of CDISC Concepts
* Good understanding of ICH guidelines
* Decent written and verbal English communications skills
* Good Team Player
* Innovative mindset

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sam Walker on [Phone number removed] or upload your CV on our website - [URL removed]
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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