Provides early input into protocol design, contracting process focused on data management issues;
Oversee the process and quality of data management work contracted out to a CRO or research collaborator. Be responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals;
Proactively communicates with project team to share project status, risk assessment and outstanding item resolution status. Ensures compliance to standard key performance indicators according to process;
Leads the development of eCRFs, database and all the other DM activities for the study handled internally by interacting with other functional area representatives;
Ensure the TMF maintenance of Data Management is on time with good quality;
Continually evaluates data management processes and applications for improvements.
Qualifications:
Educated to at least Bachelor level in Medicine, Pharmacy, Biological Sciences, or health care related disciplines.
At least 5-year data management experience in pharmaceutical company or Contract Research Organization (CRO) .