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Kelly Services Clinical Data Management & Technology (CDMT) Contractor in Cambridge, Massachusetts

Kelly is hiring a Clinical Data Management & Technology (CDMT) Contractor

  • 2-3 roles needed

  • Pay: negotiable

  • 12 months with possibility of extension up to 18 months

  • Possibility of conversion (to CDS Lead)

  • Remote

  • Therapeutic areas of priority: GI, Oncology, Rare, and Neuro

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 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

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

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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