- Coordinating and performing the collection and processing of CRF data.
- Performing data management activities, including: data receipt, data entry, and initial and final data review, and discrepancy resolution.
- Using manual and automated methods to perform clinical data review and medical review to ensure the overall integrity and consistency of the clinical trial data.
- Encoding unrecognized terminology entered into the database using MedDRA and other dictionaries.
- Identifying and resolving central and local data quality issues and maintaining standard central and local data management practices.
- Coordinating and performing DM set-up process, CRF/eCRF set-up, collector design, edit definitions, report requirement definition, requirement documentation and testing.
- Ensuring consistency in execution across assigned trial portfolio.
- University/college degree in paramedical or technical discipline
- A minimum of 5 years of experience in clinical data management, clinical research or in a clinical or bio-medical area
- Excellent English skills (both written and verbal) as well as strong communication and interpersonal skills, with an ability to work cross functionally in a globally diverse environment
- Strong computer skills, with preferred experience in one or more EDC tools and with basic knowledge of late stage clinical development process
- Excellent knowledge of ICH/GCP, including understanding of regulatory requirements and European Directives
- Other desired characteristics include good organization, analytical and presentation skills along with the ability to work independently and efficiently