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Job Details

Clinical Data Management and Technology CDMT Contractor

Location
Cambridge, MA

Date Last Verified
Aug 11,2018

Posted on
Jul 16,2018

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Job Description
Clinical Data Management & Technology (CDMT) Contractor
Must have 10-15 years of experience
Location: Cambridge, Massachusetts
Position Summary: Manages all aspects of the clinical trial data management process from study start up to database lock for trials conducted through an outsourced partner / Contract Resource Organization (CRO)
Duties and Responsibilities:
• Acts as the data expert and represents CDMT on study team as applicable
• Works with CRO to ensure data collection tools capture protocol requirements
• Identifies and resolves data flow process issues in collaboration with the project team
• Defines data handling conventions, quality acceptance and auditing criteria for data collection and data deliverables
• Provides guidance and sponsor approval per CRO SOPs and process exceptions
• Serves as an internal CDMT expert for cross functional team members
• Liaises with third-party vendors in support of study team escalations
• Monitors timelines to ensure data management-related deadlines or contributions to study deliverables are proactively defined and met
Supplemental Activities:
None defined
Qualifications:
Experience: BS/RN/MS/RPH degree in health-related field preferred with 5 years of clinical data management experience in the pharmaceutical/biotechnology industry; knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management; strong comprehensive understanding of CDISC (SDTM), clinical experience in the oncology, neuroscience, or gastrointestinal preferred; EDC and coding experience with WHO Drug and MedDRA desirable
Other:
• Strong knowledge of SOPs, GCP standards and CDM systems
• Detail orientation
• Excellent written and verbal communication skills
• Ability to focus on multiple projects of different duration and complexity
• Ability to work independently with minimal guidance

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