Clinical Data Management & Technology

  • location: Cambridge, MA
  • type: Temporary
  • salary: $105 - $122 per hour
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job description

Clinical Data Management & Technology

A Global Biotech/Pharmaceutical Company in Cambridge, MA has an opening for a Clinical Data Management & Technology(DCMT) contractor position
Duration: 9+ month contract position
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)
Responsibilities:
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 Takeda 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
Working hours: 8:30 AM - 5:30 PM
Skills:
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
Qualifications:
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
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.
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