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.
Position: Expert Data Management (m / f / x)
The position: The position holder will support 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 support the study lead and partner with internal and external stakeholders to optimize Data Management technology, processes, and standards. The position will understand Electronic Data Capture / related applications and industry standards, and have fundamental technical skills in working with data received from CROs and other third-party vendors.
Roles & Responsibilities: Study Responsibility: Responsible, with strict 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. 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.
Operational Excellence: Participate, with supervision, 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 practice 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. Previous experience supporting drug development and/or post marketing in clinical research, Pharmaceutical, CRO or Medical Device setting is an advantage.
Competencies and Generic Skills: Excellent English language skills.
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