Manager, Data Management

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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

The Manager, Data Management is accountable for end-to-end delivery of clinical data management services for assigned studies, collaborating with study teams, CROs, external vendors, and partners to ensure high quality deliverables are on time 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 may manage multiple studies concurrently. This position will manage DM resources of assigned studies. 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 working on multiple phases within the medical device and/or pharmaceutical industry in one or more complex disease areas. This position requires experience in continuous improvement, project management, change management, and risk management.

Responsibilities:

Leadership, Direction, and Strategy:
- Establishes Data Management deliverables and expectations at the study level.
- Proactively identifies and manages risks to data quality and/or timelines at the study level and escalates issues to the DM program lead.
- Will manage DM resources of assigned studies; provides FSP/Vendor oversight for end-to-end Data Management activities.
- Acts as a core member of the Study Team and collaborates with other line functions to achieve study deliverables.
- Is an ambassador and Subject Matter Expert (SME) for DM.  Participates in audits and inspections as the DM SME for the study.

Project Management:
- Is accountable for the conduct of Data Management activities for assigned studies (e.g., study startup, study conduct, study closeout, and monitoring adherence to quality expectations and timelines.
- Is responsible for proper planning of DM resources for assigned studies.
- Complies and ensures compliance of DM resources of assigned studies and vendors with the protocol, Policies, SOPs, external/internal standards, program standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines.
- Is accountable for Data Management deliverables meeting/exceeding study team expectations regarding quality and time.
- Ensures Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements

Functional Expertise: Study Start-Up:
- Participates in Study Team’s start-up meeting to determine technology and study-specific data requirements.
- Meets with assigned DM staff and external vendor(s) to discuss data management responsibilities, timelines of deliverables, and development of study plans/documents.
- Reviews and approves study timeline for all DM study start-up, conduct, and close-out activities and ensures alignment with program timelines.
- Contributes feedback to authors of other cross-functional study documents such as the Clinical Protocol, Clinical Monitoring Plan, Statistical Analysis Plan, SAE Flow Plan, Medical
- Management/Medical Data Review Plan, Lab Plan, Randomization (IXRS) Plan, and Protocol Deviation Plan to ensure successful data collection, cleaning, and evaluation of study results and safety data reporting.
- Identifies need for and requests new study data standards; ensures consistency of incorporation of these and other DSI data standards across assigne