Some opportunities happen only once in a lifetime – like a job where you have the chanceto 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.
This is what you will do:
The Senior Director of Clinical Data Management (CDM) has experience managing staff and projects in several programs to deliver portfolio-wide data management services from a core team of clinical data management experts and specialized 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 supporting regulatory requirements for complete and accurate data. This individual may have several therapeutic areas and specialty services within their accountabilities.
You will be responsible for:
- The performance and productivity of several therapeutic areas in data management operations while supporting or leading senior leadership initiatives to increase data management productivity and create and govern models for the following: rapid study start and database cuts/locks, cross-functional and vendor governance, oversight, and operational enhancements, models for efficiencies and relationship building for phase-centric modeling, and models for risk-management.
- 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, and ensuring that technology enhancement goals are met (e.g., implementation , roll-out, training of elluminate).
- 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, and seeking prospective partnerships for improved depth and breadth of DM service.
- Serving as a subject matter expert for various operations, including, but not limited to, the following: electronic data capture, external data standardization, collection, and processing, and the creation of standard data collection forms and associated validation checks and collection processes.
- 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 and leaders who excel in data management operations and demonstrate a next-generation aptitude.
You will need to have:
- Experience in clinical data management of 12+ years with 8 to 10 years managing reports.
- A Bachelor’s degree in a scientific discipline or equivalent (computer science, mathematics, statistics, epidemiology, biology, psychology).
- 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.
- 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 are necessary to interact with personnel at all levels within and outside the company.
- Experience leading inspection readiness and supporting multiple, global regulatory inspections.
- 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.
- Certification as a Certified Clinical Data Manager (CCDM) from the Society of Clinical Data Management
Alexionis a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Furtherinformation about Alexion can be .
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lackthereof, sex, sexualorientation, age, ancestry, national origin, ethnicity, citizenship status, marital status,pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you’re interested in career opportunities with AstraZeneca, clickhere.