| Job ID: |
DS-05269-1 - Clinical Data Manager |
| Description: |
RESPONSIBILITIES:
• Candidate will provide comprehensive data management expertise to Data Management to provide efficient, quality data management products that meet customer needs
• Serve as the Lead Data Manager on studies.
• Customer negotiation on timeline, budgetary and other data issues
• Develop presentations and present at investigator meetings
• With minimal guidance, manage delivery of projects through full data management process life-cycle.
• With minimal guidance, manage project timelines and quality issues, and identify and justify out-of-scope.
• Provide input for negotiations with vendors.
• Manage outside vendors
• Complete external data reconciliation (i.e., ECG data)
• Complete ongoing laboratory reconciliation
• Provide comprehensive data management expertise (including all operations tasks and DMP generation oversight and approval).
• Oversee the development of CRFs
• Perform comprehensive quality control procedures
• Communicate ideas for process improvement.
• Provide input in developing and implementing new technology.
• Understand and comply with core operating procedures and working instructions
• Meet objectives as assigned.
• Some knowledge of CDISC standards
• Develop and maintain good communications and working relationships with Project Team
• Interact with Project Team members to negotiate timelines and responsibilities as well as track overall timelines.
MINIMUM REQUIREMENTS:
• Degree in clinical, biological, or mathematical sciences with a minimum of 7 years of experience in a clinical data management role.
• Thorough knowledge of the data management process
• External Data Capture (EDC) experience
• Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology
• Previous experience and proven competence in managing delivery of project through full data management study life-cycle (phase I and Phase II or Phase III).
• Comprehensive understanding of clinical drug development process
• Excellent organizational, communication, and data management skills (detail oriented).
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
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Salary: $40-45,
Job Type: Contract,
Total Exp: 7 yrs,
Start Date: Asap,
Location: Fort Lee, NJ |
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