essential functions
• review and assure the quality, integrity, accuracy, and completeness of clinical trial data based on project specific guidelines.
• develop and maintain a library of effective data quality checks.
• review data exports and reports to identify, investigate, and reconcile data discrepancies with clinical operations staff and/or client’s data managers.
• prepare, review, and upload appropriate data management documents to the trial master file
• perform thorough development testing of the datasets prior to release to production, inclusive of creating test scripts and execute testing as applicable.
• author data transfer specifications (dts) for incoming and outgoing data files.
• collaborate effectively and build productive relationships across the global operations team.
• performs other job-related duties as assigned
qualifications
• 3+ years of data management experience in the clinical trials industry
• bs/ba degree or professional experience equivalent.
• demonstrated successful experience in all relevant clinical data management activities in a pharmaceutical or cro setting.
• working knowledge of clinical trial research, including fda, gcp/ich guidelines, gdpr, cdisc/sdtm standards and 21 cfr part 11
• experience working with edc systems, ., medidata rave or oracle inform
• familiarity with industry wide coding dictionaries such as meddra is a plus
• experience with relational databases and xml a plus
• excellent written and oral communication skills.
• excellent analytical and problem-solving skills
• ability to function independently.
• ability to prioritize and handle multiple tasks and projects concurrently