Job Reference: BBBH23340
Job Duration: 12 months
Start date: a.s.a.p
Description:
My client, a global Pharmaceutical company, currently seeks a strong Data Management specialist with a background in data entry to join their Basel based team on an initial 12 month contract basis.
RESPONSIBILITIES AND TASKS
*Forecasts Data Entry team resource requirements and allocates resources adequately
*Allocate tasks to the DATA ENTRY OPERATOR
*Supervises data entry and atomic data entry in CADP
*Performs Data Entry in CADP, or any other application as needed
*Is responsible for the DPP management in CADP
*Performs Data Entry Quality Control (QC)
*Performs operational checks to verify that clinical data is handled according to the protocol, applicable Quality System (QS) documents and Good Clinical Practice (GCP)
*Is the iTrack super user for CDDM (Document Management System)
*Isthe Quatro super user for CDDM
*Ensures adequate training is given to CDDM staff for CDDM applications
*Is owner of Tables & Listings document
*Monitors and supports the implementation & validation of Data Management applications
*Develops, reviews policies, SOPs, and associated documents for CDDM
*Publishes CDDM Quality Documents in Quatro
*Uploads CDDM training records in Quatro
*Is responsible for the global user administration of CDDM applications, such a CADP/ACT.EDC (as per SOP -100058)etc.
*Organizes Case Report Form / related documentation scanning, and is the contact for all (e)CRF matters related to (FDA)filing Guides Data Management staff in the use of applications/systems
REQUIRED QUALIFICATIONS AND EXPERIENCE
*Recognizeddegree in life sciences, mathematics, statistics, informatics or related disciplines is an advantage
*At least 5 years' experience working in a scientific environment
*Must be able to work to timelines and achieve project deadlines
*Fluent in spoken andwritten English, German is a plus
*Computer literate
*Good level of functional expertise in Data Management and knowledge ofmedical terminology
*Good knowledge of international clinical research regulations and requirements (e.g.,
ICH/GCP)
*Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report Form design is an advantage
*Ability to lead and coordinate the activities of the Data Entry team
*Sound knowledge of different software packages, beyond Microsoft Word, Access,
PowerPoint and Excel
*Ability to adapt quickly to new IT technologies and Clinical Data Management Systems
*Must have a high sense for organization and attention to details
For further details about this, or to discuss other opportunities within Data Management, please contact Tim Barratt on +44(0)1727 817 626 or email your CV to tbarratt@keypeople.co.uk
Industry: Pharmaceuticals
Salary: €50 - €60 per day
Salary Benefits:
Vacancy Type: Contract
Job Skills: data manager, data entry, contract, basel, switzerland, data
Contact Name: Tim Barratt
Website: -
Direct Application URL: -