Lead Clinical Data Analyst

Johnson & Johnson-posted 3 months ago
$105,000 - $165,000/Yr
Full-time • Mid Level
Warsaw, IN
5,001-10,000 employees
Chemical Manufacturing
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We are searching for the best talent for a Lead Clinical Data Analyst to join our MedTech Team located in Warsaw, IN; Raynham MA or West Chester, PA. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopedics? Ready to join a team that's reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness.

  • Collaborate with Data Management leadership (including Programming and Biostatistics) to define and document data and process standards
  • Provide in-house project support for creation, routing and approval of all system deliverables associated with clinical systems
  • Support the development and maintenance of global harmonized processes and procedures for system support
  • Support vendor evaluation, selection, contracting, and oversight activities for outsourced systems; Assist with vendor evaluation and selection activities for clinical systems
  • Work with BSDM partners, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines and milestones for study-specific systems set-up, UAT, maintenance and closeout as required
  • Lead project management activity related to the deployment of Interactive Voice/Web Response Systems (IxRS), Electronic Data Capture (EDC) Systems, CTMS, eTMF and other relevant platforms (as assigned)
  • Create, review and facilitate approval of system deliverables and facilitate appropriate quality review where applicable
  • Mentor peers through review of deliverables to minimize delays during the quality review process
  • Interface between Clinical R&D, IT and Quality including CSV regarding clinical systems, UAT, processes and other tools
  • Facilitate support requests associated with clinical systems (as needed)
  • Serve as first line of contact from study initiation through go live for each clinical study. Systems may include: CTMS, eTMF, IxRS, EDCs
  • Facilitate the development of training materials and programs related to system set-up, UAT and ongoing maintenance as well as other relevant processes
  • Represent the Medical Devices Sector on Enterprise or cross-sector Clinical System teams (as needed)
  • Assist with the implementation of study metrics
  • Analyzes complex change requests to determine feasibility for incorporation within clinical studies
  • Evaluates vendor supplied release documentation for implementation feasibility and collaborate with appropriate partners to define project parameters
  • Responsible for communicating business related issues or opportunities to the next management level
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed
  • A Bachelor's degree (or equivalent) in Statistics, Computer Science or related discipline (required)
  • At least 6 years of system support in clinical research within Medical Device or Pharmaceuticals
  • Experience with at least one clinical system (EDC, CTMS, eTMF and IxRS) is required
  • Previous experience in Clinical Operations preferred
  • Demonstrated ability to manage a project in a team environment to deliver critical milestones
  • Strong proficiency in more than one Clinical system. Advanced certification preferred
  • Experience with CDISC STDM preferred
  • Excellent verbal and written communication skills
  • Knowledge of GCP and SDLC
  • Medical, dental, vision, life insurance
  • Short- and long-term disability
  • Business accident insurance
  • Group legal insurance
  • Consolidated retirement plan (pension)
  • Savings plan (401(k))
  • Long-term incentive program
  • Vacation - 120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Washington - 56 hours per calendar year
  • Holiday pay, including Floating Holidays - 13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
  • Condolence Leave - 30 days for an immediate family member; 5 days for an extended family member
  • Caregiver Leave - 10 days
  • Volunteer Leave - 4 days
  • Military Spouse Time-Off - 80 hours
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