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Alexion

Clinical Operations Systems Steward Lead

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Job Location

Zurich, Zurich, Switzerland

Job Description

Position:  Clinical Operations Systems Steward Lead (f/m/d)



Reports to: Senior Manager, Clinical Operations System Integrity



Location:    This position will be based from Alexion’s Zurich office



 



Position Summary





The Clinical Operations Systems Steward Lead takes a leadership role in the management of Alexion clinical systems including eTMF, CTMS, and eArchive.  Ensures integrity and consistency of clinical system data through data stewardship activities and management of integrations between multiple internal and external systems.  Supports system configuration and upgrade activities.  Provides subject matter expertise and support for clinical system end users. 

 

Job Duties & Responsibilities



 




  • Provide stewardship of eTMF, CTMS, and eArchive systems and associated data and content to ensure these systems serve as reliable information sources, supporting ongoing clinical development activities and health authority inspection

  • Manage reference data sets to ensure consistency across studies and systems

  • Provide systems expertise to business process development efforts

  • Liase with clinical study teams and vendors to ensure accuracy of data in clinical systems

  • Support system configuration activities, system upgrade rollout, and integrations with other internal and external systems

  • Supports data and content migration activities resulting from acquisitions, partnerships, and  legacy system migrations

  • Provide subject matter expertise and Tier 1 support for clinical system end users

  • May lead data integration and data review projects and represent Clinical Operations System Integrity team at cross functional meetings



 

Essential Qualifications



 




  • 3+ years experience with clinical development processes and associated systems

  • Demonstrated critical thinking capabilities with forward looking perspective and comfort with ambiguity

  • Strong verbal, written, and organizational skills with a team-oriented approach

  • Familiarity with MS Office software including: Word, Excel, Outlook, Visio, Project and PowerPoint



 

Preferred Qualifications



 




  • Hands on experience or certification with Veeva Vault products highly desirable

  • 2+ years eTMF experience desirable

  • 2+ years experience working with CTMS systems desirable

  • Experience with system validation, implementation, and integrations desirable

  • Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development is desirable

  • Experience working in clinical research / medical environment, including exposure to medical or regulatory records and associated systems highly desired


 



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 and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). 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) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. 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, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.




Location: Zurich, Zurich, CH

Posted Date: 10/29/2020
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Alexion

Posted

October 29, 2020
UID: 77739221

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