Looking for a Clinical Data Management Professional who thrives in a dynamic, international environment and brings a strong commitment to data quality and regulatory compliance.
Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation and all changes during the life cycle of clinical trials.
Conduct medical review of all trial subjects in assigned clinical trials to ensure high-quality, consistent medical data. Ensure patient safety and adherence to protocols, Good Clinical Practice, ICH Guidelines, local regulations, and SOPs.
Bachelor degree in Pharma or Life Science. pharmaceutical sales experience, preferably with diabetes products. Consistent record of meeting or exceeding sales targets
Facilitate and manage corporate quality audits and regulatory audits and drive the Supplier Qualification Program, including the identification, evaluation through audits, monitoring, maintenance, and re-qualification of vendors.
Identify and tabulate the training needs of the field force in the zone by attending predefined meetings. Plan, coordinate, and execute induction training for all newly recruited Field Executives within a predefined time frame.
Masters or Bachelors degree in Engineering, Pharmacy, or a Supply Chain-related field, with excellent written and verbal communication skills and a strong command of English.
Maintain regular communication with internal stakeholders to gather business requirements, support strategic pricing projects, and ensure customer satisfaction through quality support
Support affiliates in updating local requirements based on regulatory agencies guidance and input from affiliates, distributors.
Manage working relationships with key stakeholders. Ensure compliance with regulatory requirements and provide strategic product direction to teams.