Senior Manager, External Data Acquisition and Processing (m/f/d)

Daiichi Sankyo is seeking a Senior Manager for External Data Acquisition and Processing to join the Biostatistics and Data Management team. The role sits onsite in Paris, France, with a secondary location in Germany, and is designed for a senior professional who can steer the end-to-end handling of external data from third-party vendors. This position would suit someone who enjoys leading cross-functional initiatives, shaping data workflows, and ensuring data quality and regulatory compliance across multiple clinical programs.

As a global biopharmaceutical company with roots dating back to 1899, Daiichi Sankyo operates in more than 30 countries and employs over 19,000 people. The company focuses on breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders, and is guided by its 2030 vision to be an innovative global healthcare company contributing to the sustainable development of society. The Senior Manager EDAP will play a pivotal role in delivering high-quality external data to support clinical trial decisions and regulatory submissions.

The role is based on an onsite arrangement in Paris, FR 92500, with a second location in Germany, and would suit an experienced data management professional who can lead external data acquisition, integration, and data governance across the Clinical Data Repository and related systems. The ideal candidate will combine hands-on expertise with strategic oversight to drive quality, efficiency, and compliance in a complex, regulated environment.

Day-To-Day Responsibilities For The Senior Manager External Data Acquisition And Processing

The Senior Manager EDAP provides strategic oversight and hands-on leadership for the flow of external data across the clinical trial portfolio, ensuring platforms for external data collection, data conformance tools, and vendor-delivered data are ready and delivering high-quality, compliant results. They act as a technical subject matter expert for systems setup and maintenance, guiding Business Administrators and serving as a back-up when needed, while collaborating with information technology, CRO partners, and other stakeholders to meet data delivery expectations.

The work includes steering the external data receipt and processing to ensure complete, timely, and accurate data availability for all studies, and leading the acquisition, integration, quality oversight, and delivery of all external data types in line with protocol, ICH, GCP, and GSOPs. Standardizing procedures and driving process improvements within the Clinical Data Repository program are also part of the remit, along with proactively identifying risks to data quality, integrity, and submission timelines.

In addition, the role encompasses people leadership duties, providing feedback and formal reviews to direct reports, mentoring staff, and serving as the escalation point for EDAP activities across programs. The incumbent will participate in technology implementations and cross-functional initiatives by supporting IT and vendor teams, ensuring that data transfer documents align with internal guidelines to support inspection readiness.

Resource planning and governance are essential components, with responsibilities for monitoring team capacity to maintain data acquisition quality and timely access management. The position also leads the overall strategy for end-to-end external data integration, coordinating transfers from multiple third-party providers contracted by DSI and managing the ongoing evolution of data standards and tools used across clinical programs.

All operational activities emphasize cross-functional collaboration with vendors, internal teams, and external partners, while driving continuous improvement to reduce cycle times, improve data quality, and enhance overall efficiency in data handling and submission readiness.

The Right Candidate For The Senior Manager External Data Acquisition And Processing

• Bachelor's Degree or equivalent experience required
• 7 or more years in the bio-pharmaceutical industry with strong expertise in clinical data storage, data management processes, data standards, technology, and quality
• Expertise in external data acquisition, integration, and management; knowledge of data acquisition and integration tools and technologies
• Experience with clinical data repository management and study blinding requirements
• Proficiency with CDR systems such as Sycamore, eClinical elluminate or similar
• Experience handling external data and programming tools like SAS, J Review or similar; strong background in clinical programming, project management, and data transfer methods
• Knowledge of data acquisition, ingestion, and analytics; ability to view data in multiple formats including SAS
• Understanding of industry standards for file management, data security, and clinical trial methodologies
• Solid knowledge and experience in computer systems validation, 21-CFR-Part11 compliance, drug development, and GxP
• Familiarity with industry-standard clinical technologies including CTMS, eTMF, and IRT

• Desire to participate in cross-functional initiatives, process improvements, and system optimizations that impact data quality and submission readiness
• Experience in external vendor meetings to discuss future implementations, system upgrades, or enhancements
• Track record of supporting acquisition, ingestion, and export of clinical data from external sources to enhance CDR efficiency and data transfer quality
• Ability to drive continuous process improvements using lessons learned and industry trends to improve efficiency and data integrity
• Interest in contributing to the development and maturation of system-centric external data standards across DS clinical programs

Pay And Practical Details For The Senior Manager External Data Acquisition And Processing

Employment Type: Full-time. Work arrangement: Onsite. Primary location: France (Paris, 92500). Second location: Germany.

Advice For Applicants For The Senior Manager External Data Acquisition And Processing

Lead with your external data track record. Put front and centre on the top of your resume a concise summary of your seven-plus years in clinical data, emphasizing external data acquisition, CDR management, and experience with systems like Sycamore or eClinical elluminate. Show the impact you’ve had on data quality and submission readiness through measurable results.

Demonstrate the must-have skills with concrete examples. Describe a project where you led external data transfers, ensured regulatory alignment (ICH, GCP, 21 CFR Part 11), and delivered timely, compliant data to a Clinical Data Repository. Highlight your SAS or J Review work and your experience with data standards across programs.

Prepare to talk about collaboration and leadership. Be ready with scenarios where you managed cross-functional teams, mentored staff, and served as an escalation point for data-related issues. Explain how you partnered with IT and CRO partners to meet data delivery milestones and how you mitigated risks to timelines.

Ask a concrete, job-relevant question. For example: How does the EDAP team collaborate with the Clinical Data Repository governance to ensure inspection readiness across all studies, and what opportunities exist to drive standardization of external data processes in the near term?