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For the Hungarian organisation we are looking for a
Country Lead Monitor (CLM)
within the Pharmaceuticals Division for indefinite period. Our aim is to internalize a colleague already working with us externally.

 

Key responsibilities:

  • Overall responsibility for country deliverables regarding timelines, budget and quality for assigned studies from feasibility all the way through archiving
  • Develop of country enrollment and retention plan, manage of country site selection and initiation, country risk leveling, patient enrollment and data cleaning activities
  • Develop of contingency plans, ensures ethical, regulatory and SOP compliance necessary to provide quality data required for global regulatory submissions for drug approval
  • Lead of the local study team, ensure that the CRA team receives study specific training, identifies training gaps and develops further training plans in liaison with the core study team as required.
  • Establish proper collaboration with local functions such as medical affairs, pharmacovigilance, regulatory, legal, compliance to ensure the study is conducted in accordance to local requirements and regulation
  • Manage of all feasibility activities and provides credible country feedback and ensure of all legal, regulatory and Bayer requirements are met prior to site initiation
  • Responsible for the overall quality of the study in the country by using relevant IT systems, country level corrective action / preventive action plans (CAPAs) maintenance
  • Oversee of country  TMF completeness and quality, ensuring that quality checks are performed and appropriate actions are in place to ensure files are ready for Inspection and are filed in accordance with relevant SOPs, ICH GCP and regulatory  guidelines
  • Accountable for planning, managing and tracking local study budget in close liaison with the assigned CTPS specialist as well as the core study team

Experience:

  • Undergraduate degree’ (or equivalent) with 5 years of relevant healthcare experience
  • 4 years monitoring & site management experience or 2 years of clinical trial management experience
  • Deep knowledge of R&D processes and local & global regulations
  • Knowledge of major concepts in data management and systems
  • Fluency in English is a must, knowledge of other foreign languages is a bonus
  • Computer literacy Word, Excel, PowerPoint, user level

Skills:

  • Project management skills
  • Decision-making and issue resolution skills
  • Excellent communication
  • Cross-Functional collaboration
  • Problem solving capabilities 
  • Effective time management, ability to handle heavy workload
  • Dynamic personality, flexibility

 

If you think this is an interesting and challenging position, please register yourself and upload your motivation letter with your CV in Hungarian and English here: