Senior Project Manager Clinical Operations (80-100%)

AO Foundation

AO Foundation

Infos sur l'emploi

  • Date de publication :

    13 juin 2024

  • Taux d'activité :

    80 – 100%

  • Type de contrat :

    Durée indéterminée

  • Langue :

    allemand (Courant), anglais (Courant)

  • Lieu de travail :

    Zizers

The AO is a medically-guided, not-for-profit organisation, a global network of surgeons, and the world's leading education, innovation, and research organisation specialising in the surgical treatment of trauma and musculoskeletal disorders. We have a global network of over 520,000 health care professionals. Each year we offer over 870 educational events around the world, supported by nearly 8,000 faculty members and attended by over 82,600 participants. We have around 20,000 surgeon members working in the fields of trauma, spine, craniomaxillofacial, veterinary, and reconstructive surgery. For more information, visit:  https://www.aofoundation.org/

 

Job Responsibilities:

 

  • Plan and manage clinical studies within the framework of scientific and legal guidelines
  • Prepare and coordinate and if required, conduct site initiation visits, monitoring visits and site close-out visits
  • Develop and adapt clinical investigation plans, case report forms and documents for ethics commission submission
  • Enter and validate clinical data
  • Control quality of clinical data
  • Compile and archive study documents (e.g. study protocols, clinical data, imaging etc.)
  • Periodically review study budgets
  • Provide status information on study data to AO Innovation Translation Center (AO ITC) management and sponsor as required
  • Maintain contact with principal investigators and study nurses
  • Evaluate and interpret clinical data in collaboration with the statistician, the medical advisor and the medical writer
  • Review interim and annual registry reports to sponsor in collaboration with the statistician, the medical advisor and the medical writer
  • Generate budgets for studies and present them for approval to the sponsor
  • Define resource allocation for projects and inform other groups on resources needed
  • Contractual negotiations with the sponsor and the study site 
  • Preparation of all study documents for ethical approval
  • Active support of quality management (QM) with reviewing and updating SOPs and related document
  • Lead, support and coach a team of clinical research associates, project managers and/or study assistants
  • Regularly review the performance of the employees and take necessary measures
  • Annual review of the performance and target settings
  • Regular meetings with senior project mangers, head clinical operations and head clinical science to discuss project status and resources In General:
  • Main contact person on project level for for the internal client AO Technical Commission and the external client DePuy Synthes
  • Representative of Clinical Operations, AO ITC in medical expert groups
  • Portfolio management, supervision and overview of all internal and external client related clinical research activities within Clinical Operations, AO ITC
Job Requirements:

 

  • Education: MD, DVM, Master of Science (MSc), PhD in a scientific discipline or related healthcare field or eqivalent training and experience 
  • Minimum 2 - 3 years of experience in clinical trial experience in a 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 guidelines, is required
  • Demonstrates core understanding of medical terminology, methodological aspects of clinical trial activities
  • Experience in interactions with outside and inside customers 
  • Ability to work in complex or multiple projects and exercise critical thinking with minimal supervision
  • Solid attention to detail and excellent organization skills 
  • Solid interpersonal skills and communication skills (both written and oral)
  • Ability to establish priorities, operate with a sense of urgency and collaborate (interpersonal, relationship management) with study team, cross functional team members and external partners/vendors
  • Demonstrates problem solving skills, demonstrates leadership skills, self-motivated and adaptable to a dynamic environment 
  • Flexibility and customer-focused mindset

Working for us, you can expect:

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

Contact

  • AO Foundation

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