Covance

  • Specialist I or II, Clinical and Ancillary Supplies Services, Sofia

    Job Location(s) BG-Sofia
    Job Number
    2018-18862
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    A career at Covance provides our employees the unique chance to create an immediate impact and difference in our patient’s lives. Joining Covance will offer a rewarding career, a chance to work in a high-energy & team oriented work place, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning. As a Covance employee, your work will be meaningful, the patient outcomes are real, and the results are lasting.

     

    Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.

    Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

    Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.

     

    Overview

    As a Specialist CASS, you will support the delivery of the Clinical and Ancillary supplies component of assigned studies within a country or a region, act as contact with study team during clinical and ancillary start-up activities including input to the development of Clinical Trial Supplies Plan or Clinical Trial Supply Flow for a given group of countries in a region. You will perform and coordinate label review and country translations according to set procedures for a global study and will be responsible for working with project team to ensure the required documents and processes related to supply management are communicated and obtained.

     

    Where appropriate you will be the key contact for importation logistics and document exchange to ensure smooth clinical supply transportation arrangements are agreed and set up.

    You will provide consultancy with regard to clinical & ancillary supply distribution strategy for the assigned country(ies) in a region and be responsible for maintenance of project specific clinical & ancillary supply logistics.

     

    You will work closely with drug and ancillary supply distribution, IVRS/IRT and label translation vendors during the set up and maintenance of related logistics

    Education / Qualifications

    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) AND work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.

    Experience

    • Proven relevant clinical research experience in a pharmaceutical company/CRO, including clinical and ancillary supplies management responsibility.
    • Working knowledge of ICH, FDA, GMP and other applicable regulations/guidelines; familiarity with clinical supply related documents
    • Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
    • Good organizational and time management skills
    • Excellent communication / writing skills
    • Strong computer skills with an ability to access and leverage technology alternatives
    • Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
    • 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
    • Multi-tasking capability
    • Ability to work independently

    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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