Sr Manager, Clinical Data Management

Company: Horizon Therapeutics
Location: Glenview
Posted on: May 1, 2022

Job Description:

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

Position Summary:

The primary role of this position is to support planned and ongoing clinical trials including overall management/oversight of all data management activities to ensure that studies are executed within the agreed timelines and according to the agreed standards and processes.

Responsibilities:

• Manages all assigned clinical study work, inclusive of studies supported internally or studies outsourced to a contract research organization (CRO)
• Ensures that clinical study milestones related to data management are met for assigned clinical studies
• Acts as the main point of contact for client and vendor communication on assigned clinical studies
• Oversees vendor activities for the clinical database creation and maintenance activities for assigned clinical studies
• Performs database development user acceptance testing activities in support of assigned clinical studies
• Prepares or provides a review of the data management plan and CRF completion guidelines for assigned clinical studies
• Contributes to the preparation of protocols and other clinical study documents led by cross-functional team members
• Ensures completeness, accuracy, and consistency of clinical data and data structure for assigned clinical studies
• Supports data management activities such as clinical data review, third party data reconciliation including ECGs, central lab, biomarker, IVRS, PK, SAE reconciliation, and local lab data review
• Follows standard clinical data management practices as outlined in SOPs
• Enters data queries into the EDC system to be resolved at investigational sites and manages the resolution of those queries
• Other activities as assigned
• Travels as needed to execute assigned responsibilities and tasks
  
  Required Qualifications, Skills, and Education:
  
  • 4+ years in clinical data management pharma/CRO industry experience
  • University/college degree (life science, pharmacy, or related subject preferred)
  • CCDM preferred
  • Proficient in Microsoft Office
  • Professional, proactive demeanor
  • Good written and verbal communication skills
  • Good interpersonal and project management skills
  • Able to collaborate effectively with internal and external study management teams to meet project timelines
  • SCDM Certified Clinical Data Manager (CCDM) preferred
  • Familiar with CDASH/CDISC standards.
  • Knowledge of MedDRA and WHODrug coding
  • Good knowledge of EDC systems, Medidata Rave preferred
  • In-depth knowledge of clinical data management processes
  • Broad knowledge of the drug development process
  • Has a good understanding of regulatory guidelines and issues (i.e., ICH GCP), and understands the connection to DM deliverables
    
    Physical Demands (additions as needed):
    
    • Ability to sit and stand for extended periods of time
    • Ability to carry, handle and reach for objects
    • Manual dexterity to operate office equipment, e.g. computer, phones, etc.
      Horizon Core Values & Competencies:
      
      Growth
      
      • Manages Ambiguity
      • Strategic Mindset
      • Demonstrates Self-awareness
      • Cultivates Innovation
      • Develops Talent
        
        Accountability
        
        • Drives Results
        • Ensures Accountability
        • Decision Quality
          
          Transparency
          
          • Courage
          • Collaboration
          • Instills Trust
            
            Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law.
            
            Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

Keywords: Horizon Therapeutics, Glenview , Sr Manager, Clinical Data Management, Executive , Glenview, Illinois