Clinical Trials Senior Analyst

hace 4 semanas


Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

Are you passionate about clinical trials and ensuring compliance with Mexican importation and exportation laws? We are looking for a Clinical Trials Senior Analyst to join our team at Novo Nordisk in Mexico.

The Position

As a Clinical Trials Senior Analyst, you will be responsible for:

  • Ensuring compliance with importation and exportation laws, maintaining close communication with CDC TMs to align lead time expectations for new trials.
  • Anticipating potential risks and taking effective actions to avoid them, escalating any quality issues to the line manager.
  • Requesting in advance all necessary information from the importer to ensure that products will be released from customs on time.
  • Following up on any medicine and clinical supplies to be imported until its final destination.
  • Safeguarding company resources by ensuring the best use of them and searching for new ways or providers that make the process more agile without compromising ethics and quality.

Qualifications

To be successful in this role, you will need:

  • A degree in Chemist Pharmacobiologist, Pharmaceutical Engineering, Biologist, or a similar field related to health science.
  • At least 3 years of experience as a Clinical Trials Assistant, preferably working with Imports, with demonstrated skills in core competencies.
  • Knowledge of clinical trials imports and Mexican importation regulations.
  • Advanced English proficiency.

About the Department

Our team in Mexico is responsible for running all clinical development activities from the initial planning of clinical trials towards authority submission. We investigate patients' reactions to new drugs, compare new drugs to existing products, and run a set of pre-specified trials in human beings. Our department provides Biostatistics and Programming, Clinical Reporting, Data Management, Epidemiology/Real World Evidence, and Clinical Pharmacology resources, processes, and competences to all development projects. We support all development projects by providing means for process alignment and optimisation, competency development, knowledge sharing, and training with regard to trial planning and execution.



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