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