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Senior Clinical Data Manager

Norwood, MA 02062

Posted: 09/11/2018 Job Category: Clinical: Data Management Job Number: 2114

The Senior Clinical Data Manager, works closely with the Data Management, Clinical Operations, Biostatistics other members of the Development Team (Clinical Research, Safety, Pharmacovigilance, Regulatory, and CMC), a well as outside vendors/CRO’ s.

Directs and supervise all aspects of the data management process, ensuring compliance with FDA regulations related to data management including external resources and CRO. Requires proficiency in the design and management of clinical trial databases, as well as programming capabilities.

Responsibilities:
  • Oversee all data management activities performed by CROs, from study start-up through database lock
  • Experience in the design and management of clinical trial databases, as well as programming capabilities
  • Ensures the proper collection, management, and storage of clinical trial data (according to regulatory requirements)
  • Provide oversight and participate in study set-up and initiation procedures such as CRF design, database design, edit check design/review, and DMP (data management plan) review
  • Assist in developing data management guidelines and quality processes to ensure final databases are accurate
  • Perform data validation and quality checks, and initiate corrective and preventive actions as indicated
  • Ability to summarize data (in tabular, graphic, and listing format) as requested
  • Participate in other activities and meetings to support Biostatistics and the Development Team as needed
  • Functional representative on project teams, study teams, development teams including multi-disciplinary interactions
  • Represent data management and effectively communicate requirements, strategy, timelines, and deliverables at internal cross functional team meetings and meeting with external vendors


Qualifications:
  • Bachelor’ s or Master’ s degree in scientific, biological, statistical, computer science, or related field
  • 5 to 8 years of clinical trial data management experience
  • Working knowledge of Varying EDC Databases, including Medidata RAVE
  • Proficiency with Microsoft Office (Excel, Word, Outlook, Power Point)
  • Familiarity with ICH GCP as well as general knowledge of industry practices and standards such as CDISC-SDTM data standardization specifications
  • SAS programming - edit checks, data validation/QC, data derivation, data import/export; experience generating listings, tables, figures desirable
  • Experience working with safety data and coding dictionaries (MedDRA and WHODD)
  • Proficiency with at least one clinical data management software system (e.g., Medidata RAVE, TrialMaster)

Demeika Roberts

Demeika is known for her enthusiasm in working closely with hiring managers to assess their needs, creatively solve problems, and passionately help candidates find their “perfect fit” dream jobs.

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