To take on responsibility for operational planning and management of clinical trials, we are looking for a highly motivated Clinical Trial Manager.

The challenging and diverse position will include the following tasks and responsibilities:

  • Head the clinical study team
  • Develop clinical outsourcing specifications to facilitate bid templates and selection of clinical research vendors (e.g. CRO, laboratories)
  • Management of interfaces and definition of operational specifications for MPAG vs clinical research vendors for conduct of clinical trials
  • Ensure optimal administrative/operational monitoring of clinical studies (includes participation in feasibility assessments, site selection, site visits/co-monitoring, management of Investigator/study site interactions, etc.)
  • Day to day interaction with the CRO, third party vendors and study sites to ensure sponsor’s oversight responsibilities
  • Management of trial budget
  • Ensure all trial deliverables are met according to timelines, budget, operational procedures and quality/GCP standards
  • Development/preparation of relevant sections of clinical study protocols and related documents in collaboration with CROs; development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans
  • Contribute to the development of clinical sections of regulatory documents, such as IBs/briefing books/safety updates/CTA/BLA submission documents, responses to Health Authority (HA) questions, etc. as needed
  • Ensure maintenance of Trial Master File in strict compliance with ICH/GCP and internal SOPs
  • Ensure clinical documents (or copies when applicable) are filed in appropriate designations (e.g. regulatory repository) and ensure that an up-to-date audit trial is maintained
  • Assist with drug/lab supply management for the clinical trials
  • Update regularly all trial information databases and tracking systems in order to manage accuracy of information
  • Support development of standard processes, planning and resource management tools and performance metrics to achieve excellence in clinical program management