Passion for Innovation. Compassion for Patients.With over 120 years of experience and more than 17,000 employees in over 20 countries, 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 strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.For our European Headquarters in Munich or other affiliates in Europe, we are looking for aManager Data Management (m / f / x)The positionThe position holder will manage, with direction, end-to-end delivery of data management services for assigned studies, collaborating with CROs and other vendors to ensure high-quality deliverables are on time and within budget.The position holder will partner with internal and external stakeholders to optimize Data Management technology, processes, and standards.The position will have a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third-party vendors.The position holder may act as a Biometrics Project Manager to plan and coordinate cross-functional Evidence Generation execution of the study deliverables.Roles & Responsibilities:Study Responsibility: Responsible, with supervision, for study activities assigned related to the Data Management study set up, conduct, and close out. Ensure timely, to budget and accurate completion of Data Management deliverables, including but not exclusive to the Data Management Plan, Database specifications, Database build, interim data cuts, Database lock, and study archiving. Leads the data review process in collaboration with the study team to ensure data quality. Contribute, with supervision, to documents submitted to Regulatory or Pricing Authorities. Must comply with international regulations. Ensure inspection readiness as well as prepare potential audits linked to assigned studies.Vendor Oversight: With supervision, responsible for routine oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines. Participates in drafting request for proposal for CRO selection. Reviews baseline budget and timelines. Contributes to budget management and activities across the project duration.Operational Excellence: Participate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions. Maintains current knowledge of industry best practices in Data Management methodology, Data Integrity, and Data Privacy.Any other duties deemed pertinent to the needs of the business.Professional Experience & Education:Education and Experience: Related degree or equivalent experience may be considered. At least 2 years of experience supporting drug development and/or post-marketing in Clinical Research, Pharmaceutical, CRO, or Medical Device setting. Experience in oncology Therapeutic Area and/or in late phase projects is an advantage.Competencies and Generic Skills: Excellent English language skills. Good communication skills, both oral and written, in explaining in simple terms complex concepts. Solid understanding of Data Integrity and GDPR principles. Thorough knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research. Fundamental negotiation and project management skills. Ability and interest to work remotely with worldwide team members across cultures and time zones.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.
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