Clinical Trial Leader (100%)
Job Profile

Key words: 

  • Clinical trial implementation, monitoring, closing; interface to CROs

Responsibilities:

  • Acts as the face of Alentis towards external vendors and partners
  • Manage and execute the clinical trial preparation and conduct:
    • Contribute to and coordinate the development and approval of study documents such as the protocol, ICF, study-specific guidelines, regulatory documents, monitoring, data management and statistical analysis plans and clinical study report, in accordance with internal SOPs and GCP requirements
    • Contribute to the development of regulatory documents, responses to Health Authority, EC/IRB and DSMB questions
    • Oversee forecasting of IMP and study material supplies
    • Review and approve feasibility (RFI, RFP), contribute to vendor selection and contract preparation
    • Plan, organize and lead Investigator meeting and training events & review related material
    • Ensure adhesions of timelines and budget with the agreed frame
    • Oversee monitoring activities and ensure trial data quality
    • Proactively address issues (e.g. enrolment), identify and implement actions to keep study on track in a timely fashion. Escalate unresolved issues and mitigation options to the Management Team
    • Support/coordinate inspection readiness, audits and CAPA resolution activities and ensure satisfactory outcome
    • Ensure that proper study documentation is maintained and archived in the (e)TMF
    • Oversee database lock activities to ensure timely data availability and coordinate study closure as needed
  • Provide clinical operations input to the Clinical Development Plan
  • Contribute to the development and improvement of clinical SOPs
  • Maintain training records to ensure appropriate level of competence in compliance with GCP and SOPs.

Qualifications, Experience and Competencies

  • Master degree or equivalent university education/degree in life science or healthcare
  • ≥5 years experience in clinical study management (incl. early trials) is required, ideally in a biotech setup
  • Demonstrated expertise in global clinical project and risk management
  • Thorough understanding of the drug development process
  • Experience in fibrotic diseases is an upside
  • Advanced knowledge of current clinical trial regulations (e.g. ICH, GCP)
  • Strong communication and presentation skills
  • Fluent in English (additional languages advantageous)
  • Demonstrated project management experience and leadership skills
  • Experience in managing global studies requiring the management complex interactions (e.g. central reading of imaging results)
  • Strong experience in executing of the entire range of clinical trial activities (from preparation, initiation to execution and reporting)
  • Strong experience in selecting and managing external service providers and vendors.
  • Very good understanding of clinical trial budget
  • Ability and willingness to travel internationally
  • Pro-active and problem-solving attitude, acting with sense-of-urgency and applying an entrepreneurial mindset
  • Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland

What we offer:

  • The opportunity to contribute to the next-generation strategy of a Biotech leader in the field of fibrosis
  • A world-class learning environment and dedicated mentorship
  • Fair compensation for your work and flexible working environment

Please submit your application at: career@alentis.ch