Covance

  • Clinical Project Leader - Sponsor Dedicated

    Job Location(s) UK-London | UK-Reading
    Job Number
    2018-22354
    Job Category
    Clinical Trial Management
    Position Type
    Full-Time
  • Job Overview

    The CPL is a member of the Project Team and has overall responsibility and accountability for the execution of the clinical operations strategy of the project on a regional or global level, as assigned. The CPL is responsible for coordinating and managing the clinical operations and local site services maintenance team, providing leadership and expertise to ensure successful execution of the site selection, clinical operations and IRB/IEC/regulatory maintenance project deliverables (quality, timeline, budget and scope).

     

    This role requires collaboration within a matrix environment, proactive internal/external communication, and exceptional strategic planning, risk management and organizational skills.

     

    As a Clinical Project Lead your main responsibilities will be:

    • The Clinical Project Leader (CPL) is responsible for the set up and progress of a clinical trial/study within the allocated countries, ensuring compliance with company quality standards and regulations in force, the forecasted timelines, milestones and budget.
    • The CPL represents the countries in his/her perimeter at the global Clinical Trial Team (CTT) and is the main contact for the Regional Trial Manager (RTM) and global CTOM.
    • He/she ensures liaison with other CTT members (CSD, SDM, TSOM…).
    • He/she leads the monitoring teams in the designated countries for his/her trials
    • He/she represents the CSU at Medical Affairs/Business Unit meetings to feedback on study progress
    • Is accountable for set-up activities according to the company standards, regulations in force and country generic administrative timelines (submission to ECs/IRBs/HAs, approvals, contracts with sites, local AEDs), and that committed targets and timelines are met at all steps and until study completion (recruitment, active/inactive sites, deadlines for DMCs, DBL, closure of sites, archiving).
    • Is the first point of contact for Regional Trial Managers (RTM), other global CTT members and the local monitoring teams.
    • Is the first point of contact for Medical Affairs/Business Units for locally initiated studies, providing input to feasibility, study design and budget development and providing feedback on study progress.
    • Organizes kick-off meeting with local monitoring teams (MT).
    • Organizes training of monitoring teams (study procedures, study devices, monitoring plan,…).
    • Organizes investigators meetings.
    • Provides support to MT (protocol, monitoring plan, CRF, tools…)
    • Prepares or arranges the preparation of protocols, written subject information, other essential documents, CSR, etc. for studies initiated locally

    Education / Qualifications

    Required:

     

    • University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
    • In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
    • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
    • Thorough understanding of the drug development process.
    •  

     Preferred:

     

    • Working knowledge of Covance SOPs.
    • Experience as a Senior Clinical Research Associate, whether internal or external.

    Experience

    Previous Clinical project management experinece is required.

    Previus SSU activities experience is required.

    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.