Associate Director, Data Management Processes, Training, and Inspection Readiness

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 Associate Director, Data Management Processes, Training and Inspection Readiness, is accountable for the end-to-end delivery of data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and other vendors to ensure high quality of deliverables to support drug development processes and global submissions.

This position provides leadership within Data Management by partnering with internal and external stakeholders to optimize processes, technology, and standards. This position ensures quality delivery of data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for ensuring all clinical trials meets quality requirements and best practices. This position serves as a subject matter expert for internal data management resources in operating processes, department training, and inspection readiness. This position requires an excellent knowledge of Data Management services and scope, training requirements and provision, as well as inspection readiness and regulatory requirements. This position requires excellent 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 medical terminology capture and reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical device and/or pharmaceutical industry across complex disease areas, and experience with regulatory submissions and inspections. This position requires skills in working in a fast-paced environment, continuous improvement, project management, change management, and risk management.

Responsibilities:

Leadership, Direction, and Strategy:

Leads development and implementation of Data Management departmental strategy and solutions related to process development, improvement, and training. Lead and coordinate development of DM processes and templates and ensure consistent execution of tasks and activities across programs. Identifies opportunities for process and workflow improvements and collaborates with Data Management SMEs in review and improvement to ensure department procedures are streamlined to meet quality and efficiency goals. Collaborate with multifunctional teams within BDM operations to understand requirements and recommend training needs, processes, standards, and governance across the department. Participate in and contribute to BDM-led committees [CRO governance, standards, systems] to assess and/or implement any changes that are required to department training, compliance, or operations. Ensure appropriate Data Management representation and contribute to cross-functional SOPs, development, and revisions. Coordinate and manage updates to cross-functional SOPs. Champions and facilitates change management through providing rationales, describing improved outcomes and increased efficiency to achieve regulatory compliance and/or operational excellence. Models and reinforces adherence to Daiichi Sankyo standards to Daiichi Sankyo program teams, ensures consistency in understanding and implementation of standards across Daiichi Sankyo programs. Promotes Daiichi Sankyo values and quality workplace culture, collaboration in cross-functional and multicultural settings, and builds and maintains positive relationships with internal/external stakeholders/vendors/partners.

Project Management:

Track and coordinate periodic review and renewal of Daiichi Sankyo Data Management SOPs/SOIs, along with associated templates, with appropriate departmental SMEs. Support SMEs and DM Leadership Team quality improvement initiatives within Data Management while also representing the department in multi-function Daiichi Sankyo initiatives. Organize frequent department drop-in sessions to review various processes, gather feedback, and provide additional training/guidance. Review available role-specific Data Management training modules and identify any gaps or areas for improvement.

Functional Expertise:

Prepares internal teams for audits and compliance. Develops a framework for preparation, participation, and follow-ups or corrective actions. Participates in external audits and inspections as a DM representative. Collaborate with departmental SMEs to identify gaps in knowledge and prepare training materials accordingly if necessary. Ensures adherence to data processes, methodologies, data standards, and technologies for quality delivery of DM services. Serve as a SME to DM data standards team and represents function to standards team as an extended part of committee. Organize and perform mock inspections of DM activity execution on clinical trials and review of the study TMF. Perform root cause analysis based on the findings from the inspections, and present findings and propose solutions to the leadership team for consideration of quality and process improvements.

Operational Efficiency / Continuous Improvement:

Lead knowledge sharing, training sessions, and facilitate lessons learned discussions within the department. Leverages comprehensive Data Management and procedure compliance expertise to promote and implement best practices across the Clinical Trial lifecycle. Remains current with and disseminates information about compliance updates and advancements, regulatory requirements, and emerging technology innovations. Develops and maintains networks with thought leaders in data management.10%

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)
- Bachelor's Degree in life sciences or related field required
- Master's Degree in life sciences or related field preferred

Experience Qualifications:
- 7 or more years training and compliance background and strong knowledge of FDA and EU regulatory requirements, industry audit processes, and Data Management best practices required.

- Additionally, strong knowledge of GCP, GDP, and 21 CFR preferred
- 7 or more years' experience in clinical data management experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO); oncology, immunology, or complex disease preferred
- 7 or more years of working knowledge of Clinical trial data systems and/or EDC lab management tools is a 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.