Senior Project Manager Clinical Operations Trauma
AO Foundation
vor 5 Tg.

AO Clinical Investigation & Documentation (AOCID) is an institute of the AO Foundation and the provider of choice of the AO Community in clinical research, clinical research education, and health economics.

We plan and execute the most pertinent clinical studies, design state-of-the-art clinical research education, and apply health economic techniques to validate current practice in the field of trauma and musculoskeletal disorders all in compliance with the ICH GCP (E6) guidelines and ISO 14155 standards.

We are looking for a highly motivated person to join our team in as :

After a careful introduction phase, you will take full responsibility to manage and supervise the portfolio of all clinical studies within the field of Trauma.

In this role you will be required to

  • Plan and manage clinical studies within the framework of scientific, regulatory and legal guidelines
  • Develop and adapt Clinical Investigation Plans, CRFs, and documents for ethics commission
  • Prepare and coordinate, and if required, conduct site initiation visits, monitoring visits, and site close- out visits
  • Evaluate and interpret the clinical data in collaboration with the Medical Statistician, the Medical Advisor, and the Medical Writer
  • Evaluate the study data and prepare / develop the Final Study Reports
  • Compile and archive study documents, review study budgets and periodically inform the sponsor on quality-related study data
  • Assist in optimizing quality standards and SOPs
  • Act as the first entry point for scientific questions related to clinical studies
  • Manage and supervise the portfolio of all Trauma clinical studies
  • Control the overall sponsor's budget for clinical studies and support the sponsor in achieving its strategic goals
  • Prepare and / or coordinate the relevant reports (financial, progress) for the different sponsors
  • Define attendance at meetings with the sponsors
  • Represent the institute in expert groups
  • Lead and coach a team of assigned Project Manager Clinical Operations (PMCOs) and clinical research associates (CRAs) during the entire project lifecycle, including resource planning, and budgeting
  • Regularly review the performance of the employees, including annual review and target settings, and take necessary measures or actions if required
  • In order to master this challenge you have

  • Education : Master of Science (MSc), PhD in a scientific discipline or related healthcare field, or equivalent training and experience
  • Minimum two three years of experience in clinical trial management in a medical device, pharmaceutical, biotechnology, CRO, and / or healthcare setting including prior monitoring or equivalent experience
  • Knowledgeable of clinical research operations, including interpretation and implementation of applicable regulations / ICH / GCP, ISO 14155 guidelines, is required
  • Demonstrates core understanding of medical terminology, methodological aspects of clinical trial activities
  • Ability to establish priorities, operate with a sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members, and external partners / vendors
  • Flexibility and customer-focused mindset
  • Demonstrates problem solving skills, self-motivated, and adaptable to a dynamic environment
  • Flexibility and customer-focused mindset
  • Structured and organized approach as well as leadership experience and skills
  • Professional fluency in English (German beneficial)
  • You have the chance to cooperate with a team of scientists, a versatile task in a multicultural and international environment.

    A dynamic workplace, international travel (up to 30%), further education as well as modern employment conditions are all part of the package.

    We offer

  • An interesting and varied job in an exciting and innovative organization
  • Working in a highly committed international team
  • Modern infrastructure
  • Employment conditions which match the requirements and offer a high degree of flexibility re working hours and location
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