Johnson & Johnson's MedTech Team is seeking a Lead Clinical Data Analyst to join their Orthopedics division. The role aims to improve and expand the possibilities of orthopedic treatments by developing next-generation, smarter, less invasive, and more personalized treatments. The analyst will be responsible for managing clinical systems and databases to support these innovative healthcare solutions.
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
- Advanced certification preferred
- Excellent verbal and written communication skills
