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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. This position will be based onsite and reports to the Senior Director, Data Management.
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 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
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
Exceptional communication and management skills
