Clinical Research Manager

Location
United Kingdom
Salary
Competitive salary + benefits
Posted
28 Jun 2019
Closes
28 Jul 2019
Ref
UK_99798_UK
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

 

Client: Pharma (Sponsor Dedicated)
Type: Permanent
Location: UK

Responsibilities

  • Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) 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, Merck policies and procedures, 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.
  • 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
  • Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
  • 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.
  • Shares protocol-specific information and best practices across countries\clusters

Qualifications

  • 5-6 years of experience in clinical research (minimum of 3 years as a CRA + 1 year as Project Manager)
  • Bachelor degree in Science (or comparable)

Please contact Urszula Kaldi on +44 (0) 203 868 1009 / ukaldi@planet-pharma.co.uk for more information

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