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Job Details

Senior Clinical Data Manager

Company: CROMSOURCE
Location: Germany, Italy
Reference: HQ00000756
Closing Date: 13 Jan 18
Type: Permanent
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

Job Title: Clinical Data Coordinator III/ Senior Clinical Data Manager   Location: Aachen, Germany or Verona, Italy Schedule: Full time, 37.5 hours a week     CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services.  We are currently recruiting for Senior Data Manager.

Requirements:

Job Title: Clinical Data Coordinator III/ Senior Clinical Data Manager

Location: Aachen, Germany or Verona, Italy

Schedule: Full time, 37.5 hours a week

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. We are currently recruiting for Senior Data Manager. We also have a number of opportunities in other therapy areas and this is a unique opportunity to become part of a rapidly growing company.

Main Job Tasks and Responsibilities

l Performing data management project duties (project set-up, project planning, project review and reporting, project coordination and mentoring) to ensure appropriate quality of data management deliverables within agreed timelines and with control over the available budget

l Writing and / or reviewing the Data Management specific study documents (e.g. Data Management Plan, Data Validation Plan, Data Handling Specifications for 3rd party vendors providing external data) to describe and define data management activities and procedures that must be followed in order to meet the requirements of the study

l Taking full responsibility for all in-house data management processes, including in-house review, data coding, data entry, discrepancy management, data validation in clinical trials to ensure appropriate quality of data management deliverables within agreed timelines within the assigned studies

l Performing the eCRF design and creation of the annotated CRF under consideration of the SDTM standards

l Program or supervising the setup of the clinical trial database and the adjacent data validation routines within the clinical data management system (CDMS)

l Programming data listings and complex validation checks in SAS and /or PL/SQL

l Perform project related communication with all internal and external parties

l Performing consultancy for clients with respect to Data Management processes to allow for smooth conduct of the project

l Liaise with internal business units as needed in the study conduct

l Performing data management training or presentations for internal/external clients ensuring their high scientific level

Education and Experience

l Higher education in sciences, medical or paramedical sciences, medical information specialist or other equivalent scientific training

l Excellent knowledge of data management and the relevant knowledge of guidelines for the conduct of clinical trials and medical investigations (e.g. ICH-GCP, EN ISO 14155)

l Excellent knowledge in the conduct of EDC trials preferably with TrialMaster, Rave, Oracle Clinical RDC or other EDC tools

l Good programming knowledge of SAS and SQL

l At least five years of practical experience in data management within the conduct of all stages of a clinical trial

l Ability to work to tight deadlines and manage time effectively

l Fluent English written and verbal communication

If you have the experience needed for this position, please contact Victoria Wilson, Recruitment Manager at CROMSOURCE, and send your CV in WORD format to vicki.wilson@cromsource.com

Why CROMSOURCE

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Keywords

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Clinical Data Coordinator, Data Manager, Office-based, Permanent

Apply for this job: Senior Clinical Data Manager

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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