Job Description

• Support all Data Management activities for assigned projects, including outsourced and/or insourced models. May act as the Lead Data Manager or Support Data Manager on insourced studies and act as Oversight Data Management Lead or support for outsourced studies.
• Actively participate in cross functional teams as the Data Management subject matter expert. This includes providing accurate Data Management updates and timelines during each stage of the study lifecycle, proactive communication for all Data Management topics, and complex risk assessment and mitigation planning with a firm awareness of cross functional impact.
• Lead and/or support Data Management start-up activities, such as development and review of protocols, EDC database development documentation and activities, eCRF Completion Guidelines, Data Management Plans, and cross functional collaboration.
• Ensure data collected in the clinical and vendor databases meets the requirements for analysis, including development and maintenance of Data Transfer Agreements and vendor data transfer workflow.
• Participate in all aspects of data cleaning and review, including routine data cleaning, third party data reconciliation, query management, metrics reporting, and cross functional data health communication and documentation.
• Review and contribute to cross functional study documents, such as Protocols, Clinical Monitoring Plans, Statistical Analysis Plans, Safety Monitoring Plans, Investigator Brochures, Data Safety Update Reports, publications and presentation slide decks.
• Maintain all Data Management documentation, ensuring preparedness for regulatory inspections.
• Collaborate with internal and external stake holders for data transfers and data analytics activities.

Requirements:

• Bachelor's Degree, or commensurate experience, with at least 5 years' experience in Clinical Data Management with a Pharmaceutical, Biotech, CRO, or Academic Center.
• Excellent verbal and written communication skills. Ability to communicate Data Management and EDC technical concepts to cross functional groups for awareness and understanding.
• Highly organized, collaborative, detail-oriented, outcome-oriented, and self-motivated.
• Ability to prioritize, adapt, and evolve tasks and processes in a fast-paced environment.
• Effectively manage a variety of Data Management tasks for multiple clinical studies at different stages of activity.
• Robust experience with EDC systems, including Medrio and Medidata.
• Advanced awareness of data collection and data cleaning best practices.
• Firm understanding and proven success managing vendors and data transfer workflows.
• Practical knowledge of ICH, FDA, and GCP regulations and guidelines, and general knowledge of industry data collection and reporting standards and best practices, such as SDTM and CDISC/CDASH.

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