Responsibility
– Review and contribution to technical documents
– Proper organization of documents submitted by the clinical department %28including scanning and allocation of documents into the appropriate folders%29.
– Ability to understand and apply current regulation
– Ensure end-to-end Data Management activities are conducted in accordance with high ethical and quality standards, all applicable GCP regulations and company procedures.
– Provide oversight of all data management activities outsourced to external suppliers and/or conducted in house, including but not limited to Data Management Plan, database specification development, database design programming, data reviews, coding and database locks.
– Serve as the data management point of contact for internal and external study team members
Requirements
– Bachelor’s degree in statistics/ biostatistics/ mathematics
– Previous experience at the same position – Significant advantage
