Senior/Principal Data Manager
Remote Remote, IL 00000 US
Job Purpose: Principal Data Manager performs day-to day Data Management activities. Works closely with DM manager, senior manager, or associate director to ensure end to end data management coverage of all assigned studies and consistency across study program.
This position requires the following critical abilities: • Capable of handling all DM tasks including (but not limited to) protocol review, eCRF and edit check specifications, UAT, DMP, eCRF completion guidelines, SAE and external data reconciliations, database lock activities.
• Capable of mentoring data managers and data coordinators as needed.
• Strong interpersonal skills as well as outstanding verbal and written communication skills.
Responsibilities include and are not limited to the following:
• Review protocol and attend protocol review meetings or provide feedback, as needed.
• Develop eCRF specification according to the protocol.
• Develop or lead the review of edit check specification, as well as perform/coordinate UAT.
• Author or review eCRF completion guidelines.
• Develop or lead the review of a Data Management Plan (DMP).
• Provide study metrics and status reports to internal and/or client teams.
• Perform or lead data cleaning activities.
• Perform or lead SAE reconciliation activities.
• Perform or lead external data reconciliation activities.
• Perform or lead database lock activities.
• Generate study timelines.
• Ensure approved study documents are maintained and properly stored in trial master file.
• Mentor junior team member as needed.
(a) Academic / Major: BS/BA
(b) Professional Skills:
• Advanced knowledge of Clinical Data Management process and procedure.
• Proficient knowledge of industry standards and regulatory requirements.
• Proficient knowledge of Medidata RAVE, Oracle InForm, and/or IBM Clinical Development
• Comprehension of the principles of quality, safety, risk management and compliance (ICH and GCP).
(c) Working Experience: 5 or more years' experience in clinical data management (Senior-level) or 7 or more years’ experience (Principal level)
(d) Language ability: Fluent in English.
(e) Computer Literacy: Microsoft Office Suite, MS Teams, Adobe, Medidata Rave, Oracle InForm, and/or IBM Clinical Development.
(f) Other abilities such as Communication skills: Excellent verbal and written communication and problem-solving skills.
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