Job Overview
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Location
Leeds, West Yorkshire, United Kingdom
Responsibilities
* Coordinate timelines and resources for implementing and maintaining clinical systems
* Provide oversight and coordination of the development and management of clinical study databases across multiple platforms
* Collaborate with Data Management leadership in defining and documenting data and process standards
* Support 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
* Evaluate, select, contract and oversee outsourced vendors for clinical systems
* Develop project management plans for trial execution, including timelines and milestones for study‑specific system set‑up, UAT, maintenance and closeout
* Lead deployment of Interactive Voice/Web Response Systems, Electronic Data Capture, CTMS, eTMF and other relevant platforms
* Create, review and facilitate approval of system deliverables and appropriate quality review
* Mentor peers through deliverable review to minimize delays during the quality review process
* Interface between Clinical R&D, IT and Quality concerning clinical systems, UAT, processes, and tools
* Facilitate support requests associated with clinical systems as required
* Act as first line of contact from study initiation through go‑live for each clinical study (CTMS, eTMF, IxRS, EDC)
* Facilitate development of training materials and programs related to system set‑up, UAT and ongoing maintenance
* Represent the Medical Devices Sector on Enterprise or cross‑sector Clinical System teams as needed
* Assist with implementation of study metrics and analysis of complex change requests for feasibility
* Evaluate vendor supplied release documentation for implementation feasibility and define project parameters
* Communicate business related issues or opportunities to the next management level
* Ensure compliance with all regulations, policies and procedures at the personal and company level
* Perform other duties assigned as needed
Qualifications
* Minimum 6 years of system support in clinical research within Medical Device or Pharmaceutical environments
* Degree in Statistics, Computer Science or related discipline (Bachelor’s required)
* Experience with at least one clinical system (EDC, CTMS, eTMF, IxRS) mandatory; proficiency in multiple systems preferred
* Knowledge of Medidata or Veeva systems
* Advanced certification in clinical data management preferred
* Demonstrated ability to manage projects in a team environment and deliver critical milestones
* Excellent verbal and written communication skills
* Understanding of GCP and SDLC preferred
* Experience in Clinical Operations, CDISC STDM, and training programs valued
* Travel up to 10%
Additional Information
Job Function: Data Analytics & Computational Sciences
Job Sub Function: Clinical Data Management
Job Category: Professional
Equal Opportunity Statement
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.
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