Manager, External Data Management

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

The Manager External Data Management, is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety, CROs and External Vendors for the data services they provide to support drug development processes and global submissions. This position provides expertise within Data Management by partnering with internal and external stakeholders (e.g. Central Labs, Specialty Labs, Biomarker Vendors, Companion Diagnostics, etc.)

to optimize data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol defined analysis endpoints (primary, secondary, exploratory, etc.).

This position also requires knowledge of external data concepts, working knowledge of data collections (EDC & Non-EDC), industry standards (CDISC / SDTM), and technical skills for integrating and importing external data received from CROs, Vendors and / or Partners. Performing oversight and execution of CDx development to facilitate science based CDx decision making would be preferrable. In addition, excellent verbal/written skills, analytical, organizational, and interpersonal skills for working effectively with people at different levels are some of the requirements of this role.

Demonstrated ability to self-start, be solution-oriented, collaborate effectively with diverse stakeholders, and be accountable for results by working in a fast-paced environment.

• Leads implementation of Program / Therapeutic level external data collection requirements by partnering will internal (BDM, Non-BDM Functions) and external stakeholders (Central Labs, Vendors, Specialty Labs, etc.) to drive consistency of data acquisition, processing, and reporting of diverse external data across DS Programs.
• Collaborates with DS Companion Diagnostics (CDx) & other Cross-Functional stakeholders in establishing data collection requirements at CDx Program / Therapeutic level by partnering with DS Translational Sciences, CDx Operations as well as CDx Partners.
• Participates in Contract/SOW reviews and MSA discussions of External Vendors by engaging with key cross-functional stakeholders (Clinical Operations, Clinical Biomarkers, QCP, etc.) for establishing data collection, data standards and data cleaning needs for DS Programs / Studies.
• Serve as the subject matter expert for Study Data Managers during the planning/start-up, conduct and close-out of external data management activities by managing Program / Therapeutic level external data collection process, study requirements as well as the overall process.
• Accountable for the maintenance, and peer review of key Daiichi Sankyo procedural documents (SOPs/SOIs), including external data templates, such as External File…