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