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Title:Sr. Manager, Clinical Data Management
Salary:Open
Experience:4+
Location:MA - Cambridge

Description:
The incumbent will be responsible for providing data management expertise when working with the various CROs contracted to perform data management on the clinical trials that are currently being conducted.

Responsibilities:
  • Be able to ensure that the company‚Äôs data management objectives are being carried out by the CRO with quality and in a timely manner.
  • Pprovide assistance in protocol review, and form design for newly conceived trials working either in eDC or in a paper data management environment.
  • Oversee data management activities performed by CROs.
  • Review of CRFs for completeness, content, standards, and database considerations
  • Review of Database specifications
  • Review and Management of Data Quality Plans
  • Perform data review periodically for quality issues and general data trends
  • Perform SAE review between CRF data and safety database
  • Oversee the management of non-CRF data for file format and timelines
  • Oversee the management of timelines of CROs
  • Ensure adequate filing and archiving of relevant data and documentation.
  • Work effectively as a team player with Biostatistics, Clinical, Medical, and Regulatory staff.

Requirements:

The ideal candidate will have experience working on oncology clinical trials and be able to provide critical thinking to the development of the infrastructure necessary for building an independent data management department within the company.

  • MS, BA/BS degree or equivalent in a scientific or health care field preferred.
  • Minimum of 4 years experience in clinical data management in the pharmaceutical/ biotechnology/ CRO setting.
  • Knowledge of medical terminology required.
  • Knowledge of coding dictionaries (MedDRA, WHO Drug).
  • Excellent verbal and written communication skills as well as interpersonal and organizational skills.
  • Attention to detail, ability to prioritize and handle multiple projects.
  • Knowledge of Electronic Data Capture (eDC) and related tools and processes.
  • Proficiency in MS Office applications.
  • Proficiency with data management systems.
  • Knowledge of database design and database concepts.
  • Preferable but not required: SAS, SQL, Access.

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