Manager, Clinical Research
Covance
London, Maidenhead
1d ago

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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