Covance

  • Manager, Clinical Research

    Job Location(s) UK-Maidenhead | UK-London
    Job Number
    2018-21851
    Job Category
    Hidden (23502)
    Position Type
    Full-Time
  • Job Overview

    This role is primarily accountable for the end to end performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, and procedures, quality standards and adverse event reporting requirements internally and externally.

     

    The CRM/CTL could be responsible for a particular study for several countries in a cluster.

     

    Responsibilities include, but are not limited to:

     

    • Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
    • Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
    • Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, quality standards and adverse event reporting requirements internally and externally.
    • Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
    • Performs Quality control visits as required
    • Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
    • Responsible for creating and executing a local risk management plan for assigned studies
    • Ensures compliance with CTMS, eTMF and other key systems in assigned studies
    • Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate)
    • Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
    • Country POC for programmatically outsourced trials for assigned protocols.
    • Serves local business needs as applicable in his/her country(If delegated can sign contracts and manage budgets)
    • Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
    • As a customer-facing role, this position will build business relationships and represent MSD with investigators
    • Shares protocol-specific information and best practices across countries\clusters

    Education / Qualifications

    Required:

    • Bachelor degree in Science (or comparable)

    Preferred:

    • Advanced degree, (e.g., Master degree, MD, PhD

    Experience

    Experience Requirements:

    Required:

    • 5-6 years of experience in clinical research of which 3 as CRA

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