Senior Project Manager/Study Delivery Excellence Lead

Senior Project Manager/Study Delivery Excellence Lead

Synteract

Brussels, Belgium

Position Overview

Support the Clinical Operations team with ICH/GCP expertise, regulations advice and act as a valuable member for clinical decision making that also influences operational efficiencies, effectiveness and business decisions. Support the implementation of the Internal Control Framework.

Specific tasks would include

  • Risk management oversight: facilitation of the clinical studies and the end-to-end clinical trial development process including performance management;
  • Risk-based management monitoring (Quality Control): deployment/coordination;
  • Act as a training partner: ensuring training operational excellence;
  • Audit & Inspection activities: support preparation, conduct, follow-up;
  • CAPA coordination and management following monitoring (business or independent);
  • Coordination and support of issue/escalation management;
  • Contribute to the development, improvement & simplification of standards and processes;
  • Ensure that standards and processes are implemented globally with a high level of compliance and quality;
  • Maintain ongoing communication with designated members from different departments to address risk management issues, to align corporate initiatives, to ensure end-to-end cross-functional approach, to work on trends, problems, issues, and other clinical monitoring opportunities in an efficient way.

Qualifications

  • University Degree in life science/healthcare required;
  • A minimum of 6-10 years of relevant experience in clinical development;
  • Investigation and negotiation skills, develop and implement new procedures when needed as well as predisposition to quality management, project management and process improvement;
  • In depth knowledge of regulatory guidelines, ICH/GCP and Epidemiology guidelines;
  • Ability to work well within a matrix environment;
  • Effective ability to prioritize tasks and deliver on deadlines, with high performance standards and a commitment to excellence;
  • Excellent English language skills (verbal and written).

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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