Senior Director, Clinical Data Management

Role Summary

Senior Director of Data Management is responsible for the strategic planning and oversight of the Data Management function comprised of internal and external data management professionals and data management supporting groups within biometrics and cross-functionally from safety, clinical development, and clinical operations. Participates in developing innovative ideas and testing new processes and systems for the management of clinical data.

Responsibilities

• Provide clinical data management leadership, expertise, and guidance for strategic optimized planning of clinical development in accordance with corporate objectives.
• Provide leadership and technical data management input. Represent and communicate data management activities, progress, and risks to cross- functional leads and senior management team.
• Lead efforts to establish a data-driven culture support improving business efficiencies
• bolstering use of data, reporting and analytics.
• Identify, plan, and drive strategic initiatives, policies, implementation and adherence to data manager standards and processes
• Develop SOPs, training, work processes and standards for data management activities and refine existing processes related to data management

Qualifications

• Bachelor’s degree in clinical, biological, mathematical sciences or related field is required; an advanced degree is a plus; equivalent experience may be accepted in lieu of the degree requirement
• Minimum 12 years of clinical data management experience in biotechnology or pharmaceutical industry
• Minimum 10 years of Electronic Data Capture (EDC) experience; IXRS development
• Must have strong knowledge of ICH and GCP and Data Management processes and systems
• Solid understanding of clinical drug development processes and agency filing experience
• Must have demonstrated problem solving abilities in a team environment and strong organizational skills and the ability to work in a fast-paced environment