Start-up Specialist I
Covance
Prague, Czech Republic
před 19 dny

Job Overview

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 Strut-up Specialist I in Czech Republic, Prague!

We are looking for people interested in both full-time and part-time options!

About the Job :

Within this position, your duties will include :

  • Overall responsibility for start-up of clinical trials
  • Collection and preparation of essential documents
  • ICF development as per local legislation
  • Clinical trial contracts negotiation
  • Regulatory greenlight documents collection and compilation, CTMS, e TMF,
  • Cooperation with CRAs
  • Contact with investigative sites during site start-up activities
  • Working with investigative sites to collect the required investigator and regulatory documents for a study
  • 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
  • Maintaining site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
  • Working with staff in Operational Strategy & Planning, Business 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

  • Providing logistical support of clinical trial supply coordination
  • Education / Qualifications

    University degree if benefit but not required

    At least 2 years of experience in clinical trials start up

    Experience

    Fluency in English and local language

    Working knowledge of ICH, FDA, IRB / IEC and other applicable regulations / guidelines; familiarity with investigator start-

    up documents; and investigative sites

    Good organizational and time management skills

    Excellent communication I writing skills

    Strong computer skills with an ability to access and leverage technology alternatives

    Self-motivation with the ability to work under pressure to meet deadlines

    Works well independently as well as in a team environment

    Ability to work independently

    At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

    This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.

    Job Number 2018-18625

    Job Category Administration / Clerical

    Position Type Full-Time

    Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority / Female / Individual with Disability / Veteran / Sexual Orientation / Gender Identity).

    Your confidentiality and privacy are important to us.

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