About Daiichi Sankyo Cancer Enterprise
The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.
Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.
This position has a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third party vendors. This position has 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 possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or more therapeutic areas. Finally, this position has moderate skills in continuous improvement, project management, change management, and risk management.
Leadership, Direction, and Strategy:
- Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies.
- Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studies.
- 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.
- Reviews/approves clinical study related documents that are owned by other functions (e.g., Protocols, Statistical Analysis Plans, Clinical Study Reports).
- Participates in audits and inspections.
Operational Efficiency / Continuous Improvement:
- Provides comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes.
- May participate in process improvement initiatives.
Education and Experience
- MS/BS/RN in life sciences or related field (or equivalent experience)
- 5+ years data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO)
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.