Job Description

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:

• Develop and monitor analytics information and visualizations in technology tools such as Tableau, J-Review, Smartview, etc. Translate technical information to study teams to help drive the use of the Data Review tools amongst teams. Serve as SME and oversee Managers within function to ensure proper implementation and execution of Risk Based Data Monitoring and Validation. Perform peer reviews of key DM and other Functional team study documents to assure quality of content and transfer of review items to IDRP. Assure study teams connect the Critical Data and RACT with Data Review processes. Act as issue escalation point for study teams to ensure timely and thorough problem resolution as required. Ability to work in a “start up” culture with limited support and resources

Promote Development and Implementation of Data Validation Standards, Tools, and Training:

• Assist in developing and implementing reporting and visualization tools (eg. JReview , Spotfire, etc.) to maximize the consistency, effectiveness, and efficiency of Data validation efforts across Daiichi Sankyo compounds and therapeutic areas with a focus on quality, lessons learned and inspection readiness. Develop, deliver and maintain clinical data validation standards. Analyze and report on Data Validation related metrics. Identify gaps and areas for improvement. Identify opportunities to promote data analysis and develop the analysis, trends, projections, and algorithms to support those opportunities.

Risk Based Data Monitoring and Data Validation Strategy:

• Serve as a key member of the Data Validation Team and work closely with the Director of Risk Based Data Monitoring and Validation to ensure that the data validation strategy is managed and controlled in connection with data standards. Communicate the connection between the identification of Critical to Quality (CtQ) data and processes, the Risk Assessment and Categorization Tool (RACT) and Data Validation Processes including Integrated Data Review to provide quality data that is fit for purpose. Advocate for Quality by Design (QbD) and Quality Data Review within Daiichi Sankyo and work to develop a culture that embraces these approaches. Monitor external environment and incorporate Data Validation and Quality Review industry benchmarking, best practices, technologies, and emerging solutions within Daiichi Sankyo. Progress the technology strategies in support of data analytics and the effective implementation of predictive data science solutions to drive risk mitigation.

People Management:

• Manages and provides guidance to team members, including organizing and prioritizing group tasks, performing training, and managing performance. Provides technical input and coaching to direct reports to ensure the development of skills within the team and the broader data monitoring and RBQM community. Directly support knowledge development of others on reporting and analytics tools that support the accuracy and integrity of study data. Responsible to create an environment where employees feel engaged and empowered, and take pride in their roles, responsibilities, and deliverables

Assist with other departmental functions as required:

• Represent BDM in cross-functional discussions as needed Provide a leadership role in department process development and optimization of related clinical research activities. Support Inspection Readiness activities. Contributes to development and analysis of performance metrics and identifies ways to raise department standards. Responsible for team adherence to standards and compliance.

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 required

- Knowledge of 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 preferred
- 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.

Job Tags

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