Covance

  • Start-up Specialist I

    Job Location(s) MX
    Job Number
    2018-19831
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    *Deliver of Global Site Services component of assigned studies within a country or globally. Including accountability for delivery to time, cost and quality for assigned activities.

    • Primary contact within investigative sites during site start-up activities.
    • Responsible for working with investigative sites to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor.
    • Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
    • Work with staff in Operational Strategy & Planning Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials.
    • Where applicable, provide logistical support of clinical trial supply coordination.
    • Liaise with Sponsor and Covance regulatory regarding document submission requirements
    • Assess impact of changes in study personnel  and document amendments on regulatory documents
    • Attend ongoing trainings
    • Monitor performance of start-up team with regard to project timelines
    • Prepare new investigator submission packages
    • Assess impact of study amendments on Informed Consent and other study documents
    • Other tasks and duties as assigned by Management.

    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).
    • Knowledge of science or a scientific background is preferred.
    • Advanced knowledge of computers and programs (e.g., word processing, excel, power point)
    • Ability to work in a fast-paced setting with many interruptions.
    • Requires great attention to detail.

    Experience

    At least 2 years of relevant clinical research experience in a pharmaceutical or CRO industry position with similar tasks and responsibilities.

    Strong networking capabilities

    Good organizational and time management skills

    Excellent communication and writting skills

    Strong computer and technological skills

    Self-motivation and learning with the hability to work under pressure to meet project timelines

    Works well independently and within a matrix environment

    Positive attitude and approach

    Multi-tasking capabilities

     

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