EDC Developer (Lead Clinical Analyst)
Location:
Cincinnati , Ohio
Posted:
March 09, 2017
Reference:
5938170111/4-en-us

The Johnson and Johnson Medical Device (MD) Sector Clinical Research and Development Center of Excellence (CR&D COE) is recruiting for an EDC Developer (Lead Clinical Analyst) 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.

 
  • Responsibilities include coordination of timelines and resources required to implement and maintain a variety of clinical systems as well as provide oversight and coordination of all aspects of the development and management of clinical study databases across a variety of platforms.
  • Coordination of activities will require the development of strong, productive relationships with colleagues across the MD sector.   This individual performs with little to no supervision.
  • 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
 


Qualifications
  • A Bachelor’s degree in Statistics , Computer Science or related discipline (required), with at least 6 years of system support in clinical research within Medical Device, CRO or Pharmaceuticals 
  • Experience with at least one clinical system (CTMS, eTMF and IxRS) is preferred.
  • EDC development experience 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 is required
  • Advanced certification preferred
  • Experience with CDISC STDM preferred
  • Knowledge of GCP and SDLC is required
  • This position requires up to 10% travel.
 

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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