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Clinical Programmer - Oferta z Jobs.pl

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Clinical Programmer

Nr ref.: /JOBS.pl

  • Reference Number: 895092-P

    Type of placement: Contract (12+ months) - Strong possibility to turn permanent

    Location: Basel, Switzerland

    Starting: October 2016


    Setup and maintenance of the Clinical Study Databases, in tight collaboration with the Study Data Manager
    Develop data transformation programs, including specifications according to CDISC SDTM and company's data tabulation standards.

    Main Responsibilities:

    Provides technical coaching and mentoring for sub function activities to Assistant Clinical Programmer, and/or Associate Clinical Programmers assigned on a program
    Reviews and provides feedback to Scope of Work for outsourced studies with respect to the DDE sub function's areas of responsibilities
    collaboration with the Study Data Manager
    Specification creation for the conversion of the study patient data to CDISC SDTM format. User Acceptance Testing of subsequent SAS conversion programs and the CDISC SDTM domains.
    Creation of TIBCO Spotfire Data Cleaning reports, mainly from reports templates, according the study team needs
    Is responsible for performs of complex deliverables for the sub function for one or more studies
    Contributes or leads local and sub functional working groups and initiatives
    Contributes to cross-functional or global initiatives
    Leads or participates in the local functional/cross-functional implementation of best practices and process improvement initiatives
    Effectively communicates ideas, project goals and status of work and independently presents at department meetings
    Identifies and develops solutions to complex problems
    Sets targeted timeframes for deliverables and anticipates potential scenarios that may create timeline delays
    Able to influence and negotiate a positive outcome
    Evaluates probability, impact and priorities of risks and develops and implements mitigation plan
    May also operate as a subject matter expert for a particular task for the sub-function consistently

    Qualifications and Experience:

    BA/BS degree or equivalent and at least 3 years of industry related experience
    Good understanding of Pharma Development principles
    In-depth understanding of the business of his or her sub function and the greater Clinical Data Manager organization
    Experience working with Clinical Trial protocols, Case Report Forms (CRF) and non-CRF data
    Experience on the Clinical Study life cycle from eCRF design, setup, conduct to close-out
    Ideally experienced on using Medidata RAVE System (eCRFs, Edit checks, Custom Functions)
    Hands-on experience on using/creating/verifying CDISC SDTM formatted datasets
    SAS programming skills, Custom Function skills and/or Spotfire skills
    Excellent communication skills
    Strong team player with a driving attitude
    Innovative and proactive mindset
    Fluent English in speaking/writing
    Able to cope with time pressure
    Ability to manage multiple tasks
    Relevant working/residency permit or Swiss/EU-Citizenship required


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