MANAGER CLINICAL SYSTEMS
Location:
West Chester , Pennsylvania
Posted:
February 27, 2017
Reference:
7023170123/3-en-us

The Johnson and Johnson Medical Device (MD) Sector Clinical Research and Development Center of Excellence (CR&D COE) is recruiting for a Manager Clinical Systems located in West Chester, PA, Raynham, MA, Somerville, NJ, Irvine, CA, Warsaw, IN OR Cincinnati, Ohio.  


The MD CR&D COE is being created to support all clinical activities across all business units within the Johnson & Johnson Medical Device companies. The COE organization is based on three functional teams: Franchise, Operations and Biostatistics & Data Management.  All three teams share accountability for the successful development and delivery of clinical evidence globally to internal and external (5Ps) stakeholders that drives innovation in surgical solutions and that optimizes the product lifecycle.  Each team within CR&D COE will have primary responsibility for defined areas of clinical program development, execution and dissemination.

  • The Manager Clinical Systems will be responsible for oversight and management of implementation and maintenance of clinical systems used by the Medical Device Clinical Research Center of Excellence. 
  • S/he will be responsible for ensuring the clinical systems and associated study specific configurations are developed and maintained in accordance with J&J standards, policies and procedures, while meeting timelines and budgets.
  • Interface with Clinical R&D, IT and Quality including CSV regarding clinical systems, UAT, processes and other tools
  • Be responsible for project management activity related to the deployment of Interactive Voice/Web Response Systems (IxRS), Electronic Data Capture (EDC) Systems, CTMS, eTMF and other relevant systems
  • Develop and maintain project timelines for study-specific systems set-up, UAT, maintenance and closeout as required
  • Train users in activities related to system set-up, UAT and ongoing maintenance as well as other relevant processes
  • Ensure prompt resolution of critical issues and provide timely and accurate responses to users
  • Serve as first line of contact for all support requests through system go live for each clinical study. Systems may include: CTMS, eTMF, IxRS, EDCs
  • Ensure efficient use of resources across the CoE to provide high quality clinical systems, on time and within budget by monitoring progress and conduct of their team’s respective projects.
  • This includes support of all clinical systems and requires active partnering with Clinical Operations, Franchise, Biostatistics and Data Management and  Medical Affairs as well as Information Technology and Computer Software Validation           
  • Provide leadership, direction and mentoring for their respective staff including staff personal development
  • Ensure all projects are adequately resourced to meet project deliverables and ensuring clinical system tasks remain on target to project timelines;
  • Serve as first line of contact for initiation and identification of resources required for study build: Systems may include: CTMS, eTMF, IxRS, EDCs
  • Responsible for the delivery of operational clinical systems
  • Provide design expertise to implement clinical system solutions
  • Lead all clinical system activities from identification of a need for a new system or clinical study configuration through final extract or decommission of clinical systems, partnering as appropriate with Clinical Operations, Franchise, Biostatistics and Data Management and  Medical Affairs as well as Information Technology and Computer Software Validation
  • Create, review and facilitate approval of system and study deliverables and facilitate appropriate quality review (including access reviews) where applicable;
  • Participate in vendor evaluation, selection, contracting, and oversight activities for outsourced systems; Assist with vendor evaluation and selection activities for clinical systems;
  • Analyzes complex change requests to determine feasibility for incorporation within clinical studies;
  • Collaborate with Data Management and Clinical partners to define, document and implement system standards;
  • Develop and maintain of global harmonized processes and procedures for all clinical systems and support functions;
  • Facilitate the development of training materials and programs related to system set-up, UAT and ongoing maintenance as well as other relevant processes;
  • Define, develop and implementation of clinical system metrics; Enterprise initiatives
  • Represent the Medical Devices Sector on Enterprise or cross-sector Clinical System teams (as needed)
 


Qualifications
  • A Bachelor’s degree in Statistics, Computer Science or related discipline (required), with at least 8 years of system support in clinical research within Medical Device or Pharmaceuticals and at least 1 year of supervisory experience
  • Ability to see the interrelationship of systems and procedures within a project and understand their interdependencies is required
  • Experience with at least one clinical system (EDC, CTMS, eTMF and IxRS) is required;
  • Strong proficiency in more than one Clinical system is preferred
  • Advanced certification preferred
  • Demonstrated ability to lead in a team environment to deliver critical milestones is required
  • Experience with CDISC STDM preferred
  • Excellent verbal and written communication skills is required
  • Knowledge of GCP and SDLC
 

Johnson & Johnson is an equal opportunity employer

 


Primary Location
United States-New Jersey-Somerville
Other Locations
North America-United States-Massachusetts-Raynham, North America-United States-Pennsylvania-West Chester, North America-United States-Ohio-Cincinnati, North America-United States-Indiana-Warsaw, North America-United States-California-Irvine
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Clinical Data Management

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