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IQIQVIA RDS GmbH

Local Trial Manager, Submissions Dedicated(m/w/x)

Köln
Full-timeOn-siteExperienced

Managing clinical trial submissions and study delivery for life sciences clients. 2 years clinical research experience and submissions knowledge required. Support core project team, optimize study speed, quality, and cost.

Requirements

  • Associate's degree in life sciences or related field
  • Bachelor's degree in life sciences or related field
  • 2 years clinical research experience
  • Intermediate knowledge of job area principles, theories, and concepts
  • Submissions and regulatory experience
  • Knowledge of clinical trial conduct
  • Skill in applying ICH GCP and relevant local laws/regulations
  • Broad protocol knowledge
  • Therapeutic knowledge desired
  • Strong written and verbal communication skills
  • Good command of English language
  • Strong presentation skills
  • Strong problem-solving skills
  • Planning, time management, and prioritization skills
  • Ability to organize resources
  • Ability to set objectives and provide clear direction
  • Experience planning activities in advance
  • Ability to handle conflicting priorities
  • Attention to detail and accuracy
  • Results-oriented approach
  • Good software and computer skills
  • MS Office applications including Word, Excel, and PowerPoint
  • Ability to establish and maintain effective working relationships
  • Strong customer service skills
  • Ability to work across geographies
  • High awareness and understanding of cultural differences
  • Good understanding of project financials
  • Ability to demonstrate IQVIA competencies

Tasks

  • Liaise with clinical teams to improve patient outcomes
  • Support core project team in clinical study delivery
  • Develop integrated study management plans with the team
  • Manage assigned portion of clinical studies
  • Optimize study speed, quality, and cost
  • Ensure compliance with standard processes and policies
  • Set and communicate sub-team objectives
  • Assess sub-team performance
  • Collaborate with functional groups to achieve milestones
  • Monitor progress against contract
  • Prepare and present project information to stakeholders
  • Identify and manage project risks and contingencies
  • Solve problems and implement corrective actions
  • Serve as primary or backup project contact with customers
  • Lead project sub-teams
  • Manage cross-collaboration within sub-teams
  • Support financial success of the project
  • Forecast and identify revenue acceleration opportunities
  • Manage changes in project scope
  • Implement best practices and lessons learned
  • Lead vendor management activities

Work Experience

  • 2 years

Education

  • Vocational certificationOR
  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishAdvanced

Tools & Technologies

  • MS Office
  • Microsoft Word
  • Microsoft Excel
  • Microsoft PowerPoint
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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