Responsible for ensuring the completeness, quality, and integrity of the Clinical Trial data.
Ensure data quality and consistency according to applicable regulatory requirements, standard operating procedures (SOPs), processes and data standards.
Ensure all data management activities to be compliance with GCP, relevant regulatory requirements and SOP/WI (work instructions) of company and/or Sponsor.
Ensure acknowledge, follow and to be consistent with company policies and procedures.
Act as Lead Data Manager for multiple ongoing clinical studies.
Ability to train junior Clinical Data Managers and assign tasks as required.
Ability to create and maintain DM Timelines.
Responsible for leading team activities with the sponsor, creating and maintaining the Global Library and maintaining eTMF and TMF (where applicable).
Requirements:
Bachelor's Degree or higher in a life science or related field
Minimum of 7 years of data management experience in a pharmaceutical or clinical research setting.
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