Biotech/Pharmaceutical

Data Management Contractor

Contract

Penfield Search Partners

Contact Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com

Job Description: The Data Management Contractor will be responsible for data management activities for clinical trials from start-up to close-out, as well as process improvement activities and department initiatives. This role works with internal development colleagues and external vendors to ensure delivery to time, quality, and cost expectations, and performs day-to-day data management activities according to ICH guidelines, regulatory requirements, and the company’s standard operating procedures.

Responsibilities:

  • Help ensure that management’s clinical development objectives are met with respect to Data Management activities
  • Provide operational leadership to the direction, planning, execution, collection, and interpretation of all clinical data to the highest quality standards
  • Report status of clinical data management activities to project teams and management
  • Apply project management skills and tools to meet expectations concerning execution of projects (both study and departmental)
  • Involved in data preparation for reporting clinical study results for regulatory filings, publications, presentations
  • Conduct clinical data management activities using Medidata’s Rave/ Veeva Data Management Systems, or other similar platforms
  • Create written data management plans, edit check specifications, CRF completion guidelines, data transfer specifications, as well as any other required study-specific data management documents
  • Design database structures and case report forms consistent with CDISC and CDASH initiatives
  • Work with third-party vendors to ensure timely and effective communication
  • Assist in training and developing junior data management personnel and CRO/internal staff as appropriate
  • Provide oversight of data management vendors in support of study timelines and department goals
  • Develop/lead/participate in process improvement activities resulting in increases in productivity, quality, and/or cost effectiveness
  • Maintain knowledge of current trends and developments with systems, processes and tools utilized for data management activities
  • Provide assistance with troubleshooting and correcting database issues

Qualifications:

  • Bachelor’s or advanced degree
  • Minimum 6 years’ experience managing clinical trial data in a pharmaceutical, biotech, or CRO setting; oncology trial experience desired
  • Advanced proficiency in core data management activities (e.g., case report form design, data edit specifications and data validation, creation of data management plans, attention to detail and data quality)
  • Strong track record of leading clinical data management activities; early and late stage, and submission experience are highly desirable
  • Experience with data management systems such as Medidata Rave®, Veeva, etc.
  • Exceptional communication and management skills

Tagged as: Data Management Contractor