Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives.
At Alexion, people living with rare and devastating diseases are our Guiding Star.
We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives.
We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.Associate Director, Clinical Data ManagementLocation: Barcelona, SpainReports To: Senior Director, Clinical Data ManagementThis is what you will do:The Associate Director (AD) of Clinical Data Management (CDM) has experience managing staff and projects to deliver portfolio-wide data management services from a core team of clinical data management experts while supporting specialty services, such as medical coding, laboratory management, and risk-based quality management.
This individual must have experience in a highly regulated environment and be prepared to present data and documentation in support of regulatory requirements for complete and accurate data.
This individual may have several therapeutic areas within their accountabilities.You will be responsible for:The performance and productivity of one or more therapeutic areas in data management operations while supporting or leading senior leadership initiatives.Leading direct-line and vendor-associated performance management measured by quality outputs tracked by key performance indicators while ensuring staff uses good clinical practice, risk-based processes, pro-active management of data quality oversight, and strategy for budget and resourcing.Participating in and leading process improvements within data management and across functions, including process and system enhancements and adoption roll-out by authoring, reviewing, publishing, and reviewing policies and methods in standard operating procedures, work instructions, job aids, and other training documents.Developing transparent accounting and reporting expectations based on contract and operational guidelines for all business relationships, including providers of tasks and technology, from requests for proposals to service completion.Meeting with global regulatory agencies and mock auditors in quality, performance, and system audits and inspections and ensuring that inspections meet the department performance metrics due to pro-active compliance and quality measures.Developing a team of highly productive professionals who excel in data management operations and demonstrate a next-generation aptitude.You will need to have:A Bachelor's degree in a scientific discipline or equivalent.Experience in clinical data management of 7+ years with recent and relevant experience managing projects, including deliverables and resources.Exceptional knowledge of the clinical data management and clinical development process, including the regulatory submission process for the FDA, MHRA, PMDA, Health Canada, and EU regulatory agencies and knowledge of CDASH, MedDRA/WHO-DD dictionary coding and versioning, digital technology, and data visualization technology.Exceptional knowledge and experience in clinical data operations and processes with skills supporting immediate step-in capability to start, maintain, and close-out studies, if needed.High proficiency with technology associated with current and evolving data management practices, including electronic data capture, data aggregating, data visualization and analytics, automated data bots, machine learning/artificial intelligence-based process enhancements, etc.A high ability to solve complex, abstract problems in cross-functional business collaboration and independent projects while demonstrating pro-active drive, sound decision-making, and attention to detail.Highly effective written and verbal communication skills to interact with personnel at all levels within and outside the company.The duties of this role are generally conducted in an office environment.
As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:A Master's degree in a related science field or equivalent.Recent and relevant experience managing direct reports.Some experience leading inspection readiness and supporting multiple, global regulatory inspections.Certification as a Certified Clinical Data Manager (CCDM) from the Society of Clinical Data Management.AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease.
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