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Senior Clinical Data Manager - Italy - L

Employer
ClinChoice
Location
Italy
Salary
Competitive
Start date
22 Sep 2021
Closing date
21 Oct 2021

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Job Details

Description:
A rare opportunity to join our internal team as a Senior Clinical Data Manager, located in Aachen, Germany or Verona, Italy.

Scope of the role:

The Senior Clinical Data Manager controls, co-ordinates and performs data management tasks for assigned projects in order to deliver high quality data for statistical analysis.

Position Duties & Responsibilities:

  • Performs data management project duties, such as project set-up, project planning, project review and reporting, project administration, project co-ordination and mentoring, to ensure appropriate quality of data management deliverables within agreed timelines
  • Programs or supervises the programming of the clinical trial database in the EDC environment
  • Creates or supervises the creation of the data validation plan and programs data validation checks in SAS and /or the EDC environment
  • Is responsible for creation, maintenance and locking/unlocking of the clinical trial database ensuring high-quality data processing
  • Fulfils delegated responsibility by the Biometrics Project Manager (BSPM) for all in-house data management processes, including in-house review, data coding, discrepancy management, data validation in clinical trials and clinical investigations
  • Performs communication with (internal and external) clients to guarantee sufficient exchange of relevant information and to maintain good client relationship
  • Liaises with the clinical project manager, medical writer, statistician, computer specialists 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 Data Management workflow and the relevant guidelines for the conduction of clinical trials (e.g. ICH-GCP)
  • Excellent knowledge of clinical trials and clinical investigations
  • At least six (6) years of practical experience in data management within the conduction of all stages of a clinical trial.
  • Excellent knowledge of EDC tools in the setup, conduct and closure of clinical studies and clinical investigations
  • At least 4 years of relevant experience in clinical database design and edit check programming
  • Good knowledge of SAS and/or PL/SQL
  • Good knowledge of English and local language


Who will you be working for?

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 success of these core values are evidenced by our below industry average turnover rates.

The Application Process

Once you have submitted your CV in English, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002582

or please contact Teresa.Mendez@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, Data Management, Database programmer, EDC, Programming, Validation checks, Clinical Trials, Validation data, Reconciliation Data
Skills: Senior Clinical Data Manager, clinical trials, database design, EDC, Programming, Reconciliation Data, Validation Checks, Validation Data 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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