Covance

  • Start-up Specialist II

    Job Location(s) BG-Sofia | BG
    Job Number
    2018-18332
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    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.

     

    We are currently seeking a proactive, driven Start-up Specialist II to join our expanding team in Sofia, Bulgaria. You will be working with our Sponsor, a well-known international company.

    You will have a great opportunity to develop yourself and also to learn from the best.

    Job summary: 

    Primary contact with more challenging sites or those hosting complex studies. The jobholder,

    working in a cross functional team, facilitates delivery of the site start-up (SSU) component of

    assigned studies within a country, including full accountability for delivery to time, cost and

    quality for assigned activities with minimal supervision.

    The jobholder operates within the boundaries of assigned budget, provides guidance to internal and

    site staff around process and other operational issues.

    Submits regular reports to Start-up Country Manager (SUCM) and project team regarding progress

    and challenges.

    Develops and implements strategies for the earliest possible approval of regulatory submission

    by reducing the hours allocated to activate sites, maximizing the time for patient enrolment and

    actively seeking local efficiencies within global processes.

     

    Responsibilities:

    • Oversee timely collection of required documents
    • Ensure project plans are followed
    • Review and Customize Country and Site specific ICF (liaise with IRB/ICE on issues)
    • Site contract and budget negotiation
    • Prepare submissions to IRB/IEC
    • Support Feasibility assessments at country level
    • Ensure high quality site documents are filed in TMF according to study plans
    • Ensure Start-up and Maintenance activities are on track and support study deliverables to include providing accurate projections/timelines to study sites, proactive site management, and active participation in team meetings
    • Work with Staff in Business Development and Operations to provide critical input for successful trial execution
    • Report on progress, challenges and escalate study issues in a timely fashion

    Education / Qualifications

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

    In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.

    Experience

    • Basic understanding of biology and biological processes.
    • Good organizational and time management skills.
    • Good communication skills, oral and written.
    • Exhibit general computer literacy.
    • Works efficiently and effectively in a matrix environment.
    • Fluent in local office language and in English, both written and verbal

    THERE IS NO BETTER TIME TO JOIN US!

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