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
Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to optimize Data Management technology, processes, and standards. Additionally, this position develops/proposes strategies within Data Management and collaborates cross-functionally to ensure successful outcomes for projects/studies.
This position has strong knowledge of Electronic Data Capture/related applications and industry standards, and strong skills in working with data received from CROs and other third party vendors. This position has solid verbal/written skills, analytical, organizational, and interpersonal skills and works effectively with people at different levels and from different disciplines and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position has experience working on Phase I-IV study studies within the medical device and/or pharmaceutical industry across multiple therapeutic areas and experience with regulatory submissions and inspections. Finally, this position has strong skills in continuous improvement, project management, change management, and risk management.
Responsibilities
- Leadership, Direction, and Strategy:
- Provides data management (DM) expertise and guidance to the project team regarding the data management DM activities and deliverables
- Establishes Data Management strategy at the project and/or study level for a larger number of projects/studies with greater complexity.
- Ensures data management deliverables for all studies within the project/program level meets quality , time and cost effective
- Leads functional and/or multidisciplinary teams working on projects/studies and/or initiatives.
- Lead and manage the standardized Data Management Process and Procedures for consistency across programs and organization
- Proactively identifies and manages risks at the project and/or study level for a larger number of projects/studies with greater complexity.
- May manage Data Management full-time and/or contract staff.
- Project Management:
- Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting).
- Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
- Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements.
- Functional Expertise:
- Reviews/approves clinical study related documents that are owned by other functions (e.g., Protocols, Statistical Analysis Plans, Clinical Study Reports).
- Actively participates in audits and inspections.
- Operational Efficiency / Continuous Improvement:
- Provides leadership within Data Management by partnering with internal and external stakeholders to optimize Data Management technology, processes, and standards (improving quality/inspection readiness, decreasing cycle times, and reducing costs).
- Leads multidisciplinary process improvement initiatives.
- Leverages comprehensive Data Management expertise to promote best practices across the Clinical Trial lifecycle.
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+ years of data management and/or related work experience in a medical device or pharmaceutical company, or similar environment (e.g., CRO) required
- 4+ years combined experience managing people and/or initiatives preferred
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.
