Covance

  • Start-up Specialist II

    Job Location(s) IT-Rome | IT-Rome
    Job Number
    2018-18993
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    Get ready to redefine what’s possible and discover your extraordinarypotential 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 Rome, Italy

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

    Responsibilities:

    • Act as the lead contact with investigative sites during assigned site start-up activities
    • Oversee timely collection of the required investigator and regulatory documents for a study as specified by regulatory authorities and sponsor
    • Ensure the ongoing accuracy and quality of site/study documents.
    • Ensure high quality documents are filed in (e)TMF and systems are updated on an ongoing basis ensuring Covance is audit ready at any time.
    • When applicable, work with staff in Business Development and Operations, to provide relevant input critical to successful trial execution
    • Provide accurate projections and timelines to study teams based upon country’s historical performance and agreed with Sponsor
    • Ensure project plans are followed for the Site Activation component of assigned studies, proactively engaging with key stakeholders to assure milestones are adequately represented and are being achieved and driving for solutions.
    • Participate in team meetings to report progress and challenges in trials. Identify potential risks to timelines and results and manage issues independently.
    • Review and customize country and site specific patient informed consents for compliance with local requirements and protocol
    • Proactively resolve informed consent issues and other potential difficulties with study sites.
    • Monitor start up activities to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual.
    • May negotiate contracts and budgets with investigative sites within parameters provided by SU PM and Sponsor.
    • Liaise with Covance Regulatory department regarding document submission requirements, if applicable
    • When needed review data for feasibility assessments at a country level.
    • Coach less experienced study team members as appropriate.
    • May be asked to negotiate timelines or delivery of project plan with SUPM’s under direction of senior specialist/SUCM
    • Perform other duties as assigned by management

    Education / Qualifications

    Recommended:

     

    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 2 years work experience in clinical research, including a strong

    working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.

     

    In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a

    minimum of 4 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered.

    Experience

    • Minimum of 4 years of experience in clinical development or regulatory process.
    • Significant experience of applying strong knowledge of ICH, FDA, IRB/IEC and other applicable
    • regulations/guidelines; familiarity with investigator start-up documents and contract/budgets
    • negotiation process; previous interaction with operational project teams and investigative sites
    • Significant experience of issue escalation and resolution.
    • Proven track record of effective communication and problem solving.
    • Experienced in creating and maintaining good business relationships
    • Proven ability to work under pressure with multiple internal clients with competing goals

     

    THERE IS NO BETTER TIME TO JOIN US!

     

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Tell Us About Yourself

    Not ready to apply? Connect with us to join our talent community.