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For your reference, we have included the original job posting below.
PB0080 - Principal Clinical Data Manager (#212026)
Job Number:
41202601
Company Name:
Mindbank Consulting Group, LLC
Job Location:
Irvine, CA US
Job Category:
Management & Business
PB0080 - Principal Clinical Data Manager (#212026)
83. PB0080 - Principal Clinical Data Manager (#212026) Posted:
Manager Data Processing Irvine, CA USA In-House Staff $90,000 -
$100,000 Starts: Ends:
Description: The Principal CDM (Clinical Data Manager) within Clinical Data Management will provide specialized knowledge and detailed attention to lead and carry out data management data review activities in support of one or more clinical research studies. The position is responsible for: * Working within clinical study teams as an extended team member. * Defining project timelines and executing the clinical data management operations against them, and any other priorities. * Using defined department metrics as a framework for timely and quality clinical data management deliverables. * Collaborating with peers within and outside the GDO organization to pro-actively manage data availability and integration.
Requirements: * Degree or equivalent experience in Clinical Research, Computer Science, Project Management or related field: 8 years experience, BS/BA degree with 6 years experience, or MS degree with 4 years experience. * Minimum 3 years experience in a project lead role within a clinical data management organization, preferably within medium-large pharma or CRO. * Knowledge and understanding of regulatory guidelines for the use of computer systems in clinical trials * Knowledge of Research & Development and an understanding of regulatory guidelines/requirements related to R & D (e.g., ICH, GCP, safety reporting) * Working knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.). * Competencies and essential skills in the following: cross functional relationships, communication, decision making, execution/results/process improvement, customer satisfaction * Ability to effectively interact with and influence others without direct reporting relationships * Ability to multi-task and prioritize * Planning, organizational, and project management skills * Document writing skills * Attention to detail with high quality outputs * Negotiation skills * Conflict management skills * Proactive and critical evaluation of varied and multiple aspects of trial implementation to ensure timely completion and with requisite quality * Ability to meet challenging milestones * Analytical and problem solving skills * Computer skills (word processing, spreadsheets, graphics, PowerPoint) * Ability to travel 15%
For immediate consideration, please send your resume to or call: .
