The Senior Manager, Data Visualization and Clinical Programming supports the development and enhancement of digital technology, provides clinical programming support /oversight and leads the data visualization initiative developed within the Global Clinical Data Management (GCDM) department and utilized cross-functionally to monitor data quality and vendor performance. The position manages complex abstract clinical data management technical projects and is responsible for tasks used to define how and where technologies are applied to collect, code, review, validate, and visualize clinical trial data received in-house and from external sources.
Activities used in the management and overseeing of technologies are performed to ensure complete, accurate, high quality, regulatory compliant data and seamless transfer of data from source to data visualization using electronic feeds (e.g. API).
Activities are performed according to external regulatory requirements, and internal standard operating procedures (SOPs), accepted industry best practices and established project deadlines. The position assists in the implementation of the corporate strategic plan in the GCDM department with the adoption of future technologies.
Support the Associate Director, Integration & Innovation to implement a roadmap for emerging digital technology (e.g. artificial intelligence, electronic health record, etc.) to drive Alexion into next generation technology.
Facilitate in the development of a strategic roadmap for enhanced data mapping from source to reporting in both data visualization platforms and in delivery to the Quantitative Sciences (Biostatistics) business group or other stakeholders.
Provide oversight for clinical programming activities in-house or in partnership with outsourced to CROs.
Act as the primary data management contact, when necessary, to ensure that clinical programming department standards are implemented in all studies.
Create platforms and processes for GCDM process, including data flow maps where technology is utilized in the efficient and effective collection of all data sources which result in data review, visualization, and regulatory reporting.
Support the Data Standards lead in developing core CRF standards in a validated repository tool which includes ODM terminology and allows for visual presentation to stakeholders prior to CRF standards acceptance and EDC adoption.
Support an integrated rollout strategy for implementation of new processes, standards, and/or technologies to ensure clear scope, comprehensive communication, training, assessment, and continued improvement opportunities for internal personnel and outsourced provider(s).
Assess corporate goals and business strategies to identify opportunities for implementing new cross-functional/organizational policies and methodologies as related to process changes, data collection standards, and data visualization synergies.
Experience in Clinical Data Management, including Clinical Programming, for a minimum of 5 years
Experience supporting clinical trials from a SAS programming perspective and understanding of SAS programming terminology, clinical data structures, third party vendor data imports and ability to merge data from outside sources to the case report form clinical data
Experience with the electronic data capture (EDC) system Medidata RAVE.
Experience with data integrations between clinical databases and industry standard systems (e.g., CTMS, ePRO, IXRS, Argus).
Experience with source data mapping into data visualization tools
Experience with oversight of: CDASH/CDISC (SDTM terminology), MedDRA and WHO-DD dictionary coding and versioning, SAS for data review, and software platforms across the biotechnology/pharmaceutical industry.
Possess a thorough knowledge of medical terminology and the clinical data management and the clinical trial process.
Experience with regulatory requirements and the submission process.
Experience in working on abstract problems across functional areas of the business, independently taking the appropriate corrective action, and identify and implement improvements. Able to review, interpret and evaluate clinical data.
Possess effective written and verbal communication skills necessary to interact with personnel at all levels within and external to the company.
Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously.
Boston, MA, United States
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.
Alexion Pharmaceuticals, Inc.