Covance

  • Start-up Specialist II

    Job Location(s) DE-Munich
    Job Number
    2018-26393
    Job Category
    Clinical Study Start Up
    Position Type
    Full-Time
  • Job Overview

    Covance is searching for the Study Start Up Specialist II to be preferebly located in Munich office based. Candidates from other European countries with fluent or good German language skills are also very welcome.

     

    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.

     

    Essential Job Duties:

     

    • 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 

    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 Required:
    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

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