Clinical Data Manager

• Coordinates study start-up activities, including review and sign off of source documents for the electronic data base, source completion guidelines, data validation (edit check) specifications, and the data management plan (DMP).
• Conducts ongoing data review and cleaning, oversees data entry timeliness and query management with investigative sites to ensure data quality, reconciles serious adverse events and vendor data against clinical database.
• Effectively manages assigned projects by adhering to established timelines and deliverables.
• Creates and maintains essential documents for the Trial Master File to ensure compliance to Good Clinical Practice (GCP) standards and applicable regulatory requirements.
• Performs auto and manual coding of study adverse events, medical history, and concomitant medications.
• Oversees locking of the database at study completion and works with lead programmers to ensure databases are well validated and ready for data transfer and/or statistical analyses.
• Follows operating procedures and guidelines for clinical data management activities; may lead efforts to identify new procedures and/or tools for clinical data management activities.
• Conducts protocol-specific data management training at Investigator meetings and throughout the course of the study.
• May oversee the activities of junior information analysts.
• Develop requirements for EDC including CRF and system design; performs and organizes all aspects of the clinical database build and cross-functional User Acceptance Testing (UAT).
• Develop report specifications for routine data reviews; assist with programming and QC of output.
• Perform routine data quality activities including review of standard study reports, query identification and resolution, and recommendations for improved data cleaning and collection.
• Collaborate with cross functional study team for data reviews and data cleaning activities.
• Maintain user accounts in compliance with regulatory requirements and SOPs.
• Review/revise DM related study plans including Data Quality Management Plan, Data Validation Plan, Data review plan, eCRF Completion Guidelines, and other study documents to ensure quality and standardization.
• Provide strategic input into the design of data flow across EDC and non-EDC data sources.
• Creatively define, develop, implement and enforce use of systems that simplify and improve clinical data capture and quality.
• Knowledge of industry standards (CDISC, SDTM, CDASH).
• In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11

Requirement:

• Bachelor's degree minimum requirement and 5+ years of relevant data management experience in biotechnology, pharmaceutical or CRO settings.
• Have at least 2-3 years' experience in the medical device, pharmaceutical, or biotech industry with emphasis in coding clinical data with standard dictionaries (e.g., MedDRA, WHO-DD).
• Experience in research methods and data management applied to clinical research is a plus.
• or equivalent combination of education and experience required
• Must be detail oriented, highly organized, and possess good interpersonal and communication skills required.
• Basic familiarity/experience with electronic data capture and/or other data capture and management systems is required.
• Ability to work effectively in teams is required.
• Understanding of regulatory requirements for license applications with US FDA and other regulatory agencies
• Understanding of CDISC standards including CDASH, SDTM, and ADAM.
• Global clinical trial expertise and prior therapeutic experience in vaccines studies.