Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
This position supports Daiichi’s Risk Based Data Monitoring and Validation Strategy and requires the ability to influence and effectively drive organizational change and continuous innovation and improvement. This role will assist in driving the connection between the identification of Critical to Quality data and processes, the Risk Assessment, and Data Validation with the goal of creating a culture shift to data-driven data quality. This role will help drive the functional areas to adopt a data mindset that enables better data, for faster database locks and reduction of database unlocks. This position requires a strong working knowledge of clinical data management processes, Electronic Data Capture (EDC)/related applications, industry standards, and technical skills in working with data received from CROs and other external vendors. This position requires strong verbal/written skills, analytical, organizational, and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures. Additionally, this position requires knowledge of clinical operations, biostatistics, and relevant regulatory requirements. This position requires experience in continuous improvement, project management, change management, and risk management.
Responsibilities
Deploy Data Monitoring and Validation activities for Daiichi Sankyo Portfolio of Studies:
Promote Development and Implementation of Data Validation Standards, Tools, and Training:
Risk Based Data Monitoring and Data Validation Strategy:
People Management:
Assist with other departmental functions as required:
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
– Master’s Degree in life sciences or related field preferred
– Bachelor’s Degree in life sciences or related field required
Experience Qualifications
– 7 or more years related pharmaceutical industry or Clinical Research Organization experience including at least 5 years of advanced knowledge of Data Management processes as well as risk-based quality management (e.g. Quality by Design principles; Quality Risk Identification and Management processes; root cause analysis; process mapping; etc.) and Central Monitoring required
– 7 or more years demonstrated track record of working within a global environment required
Travel
Ability to travel up to 10%
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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