PRAHS

  • Clinical Study Manager (CSM) office based Lisbon

    Job Locations - | Portugal
    Posted Date 2 weeks ago(6/4/2018 8:40 AM)
    ID
    2018-47155
  • Overview

    Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too.

    Responsibilities

    We are looking for a Clinical Study Manager office based in Lisbon.

     

    Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.

     

    As a Clinical Study Manager, you will be dedicated to one of our global pharmaceutical clients; a company that is advancing the development of new medicines with a strong focus on oncology, among other therapeutic areas. Working in this model, you will be part of the most exciting projects together with an essential pharma company and a top 5 CRO across the globe.

     

    We are seeking a Clinical Study Manager to work as an integral part of our pharma client’s global study team. The key function of the Clinical Study Manager is to provide full accountability and oversight for all assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country/study level plans (eg, timelines, budget, resource, risk and quality plans)

     

    Working throughout the lifecycle of the trial, from start-up through to database lock and closure activities, key responsibilities will include:

     

     

    • Performs or coordinates study, protocol and site level feasibility activities, including evaluation of patient population and final site selection.
    • Coordinates operational aspects for implementation of clinical trial activities from study start-up through database lock and close-out, ensuring quality and safety standards, regulations, timelines and budget commitments are met.
    • Plans and executes country study goals and commitments and ensures compliance to relevant processes.
    • Develops accurate recruitment plans and mitigation actions, and ensures recruitment is on-track for allocated studies.
    • Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.
    • Oversees site monitoring performance.
    • Responsible for management of country-level trial master file (TMF) and ensures that TMF is up-to-date and performs reviews for quality.
    • Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of corrective and preventative actions for allocated studies.

     

    Qualifications

    You are:

     

    An innovator, motivator and delivery-focused.

     

    Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

     

    • An ability to combine creativity, leadership and experience to empower a team to succeed
    • Prior experience of on-site monitoring, site management and study management
    • Confidence in your decision-making abilities
    • A current knowledge of processes, legislation and demands in clinical studies
    • A BA or BS degree in a health or science related discipline
    • Fluency in English and local language

     

     

    Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.

     

    PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

     

    For more information please visit our website: www.prahs.com

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