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IQIQVIA RDS GmbH

Local Study Operations Manager(m/w/x)

Frankfurt am Main
Full-timeRemoteSenior

Managing clinical trials from start-up to close-out for a global clinical research provider. Advanced German (C1) and local regulatory expertise required. Study start-up process and timelines knowledge essential.

Requirements

  • Bachelor’s degree and 5 years of directly related experience
  • Advanced knowledge of global clinical trial management
  • Local knowledge/expertise of regulatory environment
  • Expertise of study start up process and timelines
  • Advanced German level (min. C1)
  • 2 years’ experience of leading local/regional teams
  • Proven work experience in clinical trial project management
  • Relevant Therapeutic knowledge (Obesity) preferred
  • Experience in oversight of external vendors
  • Ability to work effectively in team/matrix environment
  • Ability to work on multiple projects
  • Proven ability to work independently
  • Effective handling of multiple priorities
  • Experience in fast-paced environment
  • Risk management skills
  • Strong organizational skills
  • Strong self-management skills
  • Strong planning skills

Tasks

  • Lead and manage clinical trials from start-up to close-out
  • Collaborate with cross-functional internal and external stakeholders
  • Ensure timely execution and budget adherence of clinical trial deliverables
  • Provide high-level country strategy and drive study progress
  • Plan and oversee clinical study execution according to global program strategy
  • Support country-level operational planning and site selection
  • Develop and contribute to program/study-specific materials
  • Communicate country status, timelines, and deliverables to stakeholders
  • Set and manage site-level goals and study-specific deliverables
  • Train CRA, Investigators, and Study Coordinators
  • Monitor and oversee vendor activities
  • Engage with local cluster team and functions from a study perspective
  • Provide input into the Country Operational Plan
  • Partner with DFM for feasibility and GCMs for local delivery
  • Approve Baseline and Revised Enrolment Plans
  • Contribute to study-level forecast for investigational product
  • Support study-level accountability and reconciliation
  • Manage the ELE process
  • Monitor clinical study execution against timelines, deliverables, and budget
  • Translate global start-up requirements into local targets

Work Experience

  • 5 years

Education

  • Bachelor's degree

Languages

  • GermanBusiness Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA RDS GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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