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Senior Clinical Data Manager, Germany - P

Employer
ClinChoice
Location
Germany
Salary
Competitive
Start date
6 Jul 2019
Closing date
5 Aug 2019

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Job Details

Description:
Job Title: Senior Clinical Data Manager

Location: Aachen, Germany

Schedule: Full time, permanent, Office based

CROMSOURCE, a mid-sized international CRO, is looking for an experienced data manager to join our growing data management team in Germany. In this role you will have the opportunity to work on a variety of clinical and medical device studies

Main Job Tasks and Responsibilities

  • 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

  • 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

  • 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

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

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

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

  • Perform project related communication with all internal and external parties

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

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

  • Performing data management trainings or presentations for internal/external clients ensuring their high scientific level

  • Attend(blind) Data Review Meetings in order to provide professional support in data management related matters

  • Attend bid defense meetings with clients to provide professional support in CDS related matters

  • Plan and conduct client meetings as required in the project content

    Education and Experience

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

  • 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)

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

  • Good programming knowledge of SAS and SQL

  • Significant practical experience in data management within the conduct of all stages of a clinical trial

  • Ability to work within tight deadlines and manage time effectively

  • Fluent in English written and verbal communication

    If you would like to be considered for this exciting opportunity please send your CV directly to myna.yeboah@cromsource.com

    Why CROMSOURCE

    CROMSOURCE is a family owned international, full-service Contract Research Organization 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 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

    Clinical Data Manager Clinical Data Coordinator Data Management Germany Aachen CRO Clinical Research Organisation Programming Senior Clinical Data Manager CDM
    Skills: Clinical Data Coordinator Location: Germany

  • 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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