Covance

  • Start-up Specialist II

    Job Location(s) HU-Budapest
    Job Number
    2018-26319
    Job Category
    Regulatory
    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.

     

    COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We have an exciting opportunity available to join our team.


    We are currently recruiting Start-Up Specialist in Hungary. This is a regular full-time position.

    • Provide local support for clinical trial supply coordination, if applicable.
    • Ensure documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.
    • Collect, review, process, and track regulatory & investigator documents required for effective and compliant study site activation.
    • Ensure that all assigned start up activities are on track and support study deliverables.
    • Proactively manage sites to ensure timely site activation.
    • Participate in team meetings to progress trials and identify site issues that might impact the timelines.
    • Escalate study issues appropriately and in a timely fashion.
    • When needed, assist in preparation of Site Activation project specific plans.
    • Provide accurate projections and timelines to study teams agreed with Sponsor.
    • Review and customize country and site specific patient informed consent forms for compliance with local requirements and protocol.
    • Review and update study documents when there are changes in study personnel/study amendments.
    • Liaise with Covance Regulatory department regarding document submission requirements, if applicable.
    • Proactively resolve informed consent issues and other potential difficulties with study sites.
    • Prepare submissions to IRB/IEC, and regulatory authorities if GRS requires input.
    • Liaise with applicable IRB/IEC and/or regulatory authorities (if applicable) regarding submission/approval issues.
    • Ensure high quality site documents are filed in the (e)TMF in a timely manner according to study plans.
    • May negotiate site contracts and budgets with sites, if applicable.
    • Proactively track progress of contract and budget milestones/developments, intervening and escalating as appropriate.
    • Undertake tasks delegated by senior team members, depending upon country and situational requirements.
    • Perform other duties as assigned by management.

    Education / Qualifications

    • University degree (life science preferred)

    Experience

    • Knowledge on local regulation, submission and budget negotiation
    • Previous experience in performing submission process independently
    • Previous work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRBIIEC regulations
    • Familiarity with investigator start-up documents
    • Previous interaction with operational project teams and investigative sites
    • 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 in 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

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