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Clinical Data Specialist /eCRF designer - Italy - P

Employer
ClinChoice
Location
 Italy
Salary
Competitive
Start date
4 Dec 2022
Closing date
3 Jan 2023

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Job Details

Description:
Location: Italy

Schedule: Full-time, permanent

CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Clinical Data Specialist/eCRF Designer. You will perform the setup of the clinical study in a modern EDC environment, reconcile external party data and create the interface to ePRO, central laboratory or IXRS systems for assigned projects in order to deliver high quality data for statistical analysis.

Position Duties & Responsibilities:
  • Designs the study mock CRF and programs the eCRF screen in the EDC tool
  • Programs the validation routines in the eCRF on the bases of the Data Validation Plan
  • Participates in the User Acceptance Testing (UAT) of eCRF screens and validation checks
  • Programs data review listings and metrics reports via SAS
  • Programs the reconciliation of external party vendor data (e.g. central laboratory, ediary, IXRS, etc.)
  • Performs communication with (internal and external) clients to guarantee sufficient exchange of relevant information and to maintain good client relationship
  • Liaises with the biometrics project manager, medical reviewer, statistician and monitors to ensure optimal data processing


Job requirements:
  • Higher education in sciences, medical or paramedical degree, medical information specialist or other equivalent scientific training
  • Excellent knowledge of clinical trials and clinical investigations
  • Excellent knowledge of Data Management workflow and the relevant guidelines for the conduction of clinical trials (e.g. ICH-GCP)
  • Excellent knowledge of EDC tools in the setup, conduct and closure of clinical studies and clinical investigations
  • Proven relevant experience in clinical database design and edit check programming
  • Good knowledge of SAS and/or PL/SQL
  • Good communication skills, team player attitude
  • Good knowledge of English and local language


We offer:
  • Working in an international full service CRO environment, not only on clinical, IMP studies, but also medical device projects too
  • A permanent employment contract
  • A competitive salary package, including country specific secondary benefits
  • An interesting training package as well as professional development opportunities
  • Flexible working solutions, including home-based working, to facilitate a good-life balance


About CROMSOURCE

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. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to 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 the clear tools needed to manage both internal and client processes with the same methodology.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement email. If you have the requirements we need, you will be invited for phone interview as the first step.

If you would like to discuss the role before applying through the website www.cromsource.com/careers/job-vacancies please contact careers@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Senior Clinical Data Manager, Clinical Data Manager, Data Management, Database programmer, EDC, EDC design, Programming, Validation checks, Clinical Trials, Validation data, Reconciliation Data, Medidata Rave, Oracle, RDC Remote Data Capture, Oracle Inform, Anju Trialmaster.

Skills: Clinical Data Manager, Senior Clinical Data Manager, database design, EDC, Oracle Location: Italy Share:

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Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

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