Description
ResponsibilitiesWork on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques. Oversee the development and maintenance of the components of the study Data Management Plan (DMP). The DMP includes Case Report Form (CRF), CRF completion guidelines, SAS annotated CRFs, data handling plan, data entry review guidelines, edit check specifications, data transfer specifications, and database audit plan. Work with clinical, biostatistics, and regulatory teams to design and develop study documents including Clinical Protocol, Case Report Forms (CRFs) and Statistical Analysis Plan (SAP). Manages the interaction with contract data management groups to ensure that data management tasks remain on target according to project timelines. Proactively organizes on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies by working with a contract data management group. Responsible for the correction of errors and discrepancies through the site query process, for documenting permanent data issues, routinely communicating issues with team members and the delivery of a quality locked database for analysis. Lead new data management initiatives such as establishing capacity for electronic data capture. Conduct CROs data management function inspections and audits. Contribute to the development and implementation of departmental policies, standards and process improvement initiatives. May mentor and develop junior clinical data management staff.
Requirements
A bachelor's degree in clinical, biological or mathematical sciences or related field, or nursing qualification. A master's degree is preferred. Equivalent experience may be accepted. A minimum of 8 years Pharmaceutical development experience with at least 4 years managing CROs is required. A minimum of 5 years previous management experience is preferred. Must have demonstrated problem solving abilities and strong organizational skills. Excellent written and verbal communication skills are required. Experience and understanding of ICH, and GCP is required. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills.. Advanced knowledge of Data Management processes and systems. Solid understanding of clinical drug development processes is preferred. Ability to develop data management processes and training is preferred
Previous people management experience is preferred. Effective problem solving skills
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