Johnson & Johnson is seeking a Lead Clinical Data Analyst to join their MedTech Team to improve and expand orthopedic treatments by developing next-generation smarter, less invasive, and more personalized treatments.
Requirements
Experience with at least one clinical system (EDC, CTMS, eTMF and IxRS) is required
Strong proficiency in more than one Clinical system.
Experience with CDISC STDM preferred
Knowledge of GCP and SDLC
Responsibilities
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
Other
A Bachelor’s degree (or equivalent) in Statistics, Computer Science or related discipline (required), with at least 6 years of system support in clinical research within Medical Device or Pharmaceuticals
Previous experience in Clinical Operations preferred
Demonstrated ability to manage a project in a team environment to deliver critical milestones
