Senior Manager (m/f/x) Data Management Processes, Training and Inspection Readiness

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.

In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

For Daiichi Sankyo Europe we are seeking qualified candidates to fill the position of

Senior Manager (m/f/x) Data Management Processes, Training and Inspection Readiness

The position:

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 excellent verbal/written skills, analytical, organizational, and interpersonal skills and works effectively with people at different levels and from different disciplines and cultures.  

Roles and 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 
• Collaborate with multifunctional teams within BDM operations to understand requirements and recommend training needs, processes, standards, and governance across the department.
• Ensure appropriate Data Management representation and contribute to cross-functional SOPs, development, and revisions. Coordinate and manage updates to cross-functional SOP’s.
• 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

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 
• 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.
• 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.

Personal skills and professional experience:

• Master's Degree in life sciences or related field    
• 7 or More Years ecperience with Training and compliance background and strong knowledge of FDA and EU regulatory requirements, industry audit processes, and Data Management best practices. Additionally, strong knowledge of GCP, GDP, and 21 CFR.
• Clinical data management experience 
• Working knowledge of Clinical trial data systems and/or EDC lab management tools is a plus
• Fluent business English (oral and written)

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

For more information: www.daiichi-sankyo.eu