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Covance Romania currently seeking a pro-active Start Up Specialist (GS - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

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  • AdresRomania,
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Covance Romania currently seeking a pro-active Start Up Specialist (GS

Nr ref.: /JOBS.pl

  • COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

    You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities.

    This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
    We are currently seeking a pro-active GSS Specialist II to join our expanding CoSource team in Romania.

    About the job:

    Collect, review, process, and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, ICH GCP guidelines, EU Clinical Trial Directive, FDA Regulations and the Investigator Package Plan
    • Assist in review and approval of regulatory & investigator documents for study site activation and drug shipment trigger
    • Assist in preparation of project specific plans for the GSS component of assigned studies
    • Assist in review of core English patient informed consents for compliance to international requirements and protocol as applicable
    • Assist in reviewof core Country patient informed consents for compliance to country requirements and protocol as applicable
    • Assist in review of investigative site specific patient informed consents for required elements
    • Maintain and update document tracking information in the Trial TrackerTM Site Information Module and other tracking logs
    • Assess impact of site personnel changes on regulatory documents and process/review new documents according to GCP/ICH guidelines

    About you:

    University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)

    Good organizational and time management skills
    • Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project teams and investigative sites preferred
    • Good communication skills, oral and written
    • Self-motivation with the ability to work under pressure to meet deadlines
    • Works well independently as well as in a team environment
    • Detail and process oriented
    • Positive attitude and approach
    • Interact with internal and external customers with high degree of professionalism and discretion
    • Multi-tasking capability
    • Computer proficiency (MS Office - Word, Excel, Power Point and Internet skills), aptitude for training, capable of operating standard office equipment (e.g. fax, copier etc.).
    More than 2 years of experience in the field.




    EEO Employer

    Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.


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