Johnson & Johnson is looking to solve the problem of managing clinical study databases across various platforms, and is recruiting a Lead Clinical Data Analyst to join their MedTech Surgery business to oversee and coordinate the development and management of these databases.
Requirements
- Experience with at least one clinical system (EDC, CTMS, eTMF and IxRS) is required
- Strong proficiency in more than one Clinical system
- Advanced certification preferred
- Experience with CDISC STDM preferred
- Knowledge of GCP and SDLC
- Database Development
Responsibilities
- Collaborate with Data Management leadership 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
- 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
- Create, review and facilitate approval of system work and facilitate appropriate quality review where applicable
- Mentor peers through review of deliverables to minimize delays during the quality review process
- Coordinate between Clinical R&D, IT and Quality including CSV regarding clinical systems, UAT, processes and other tools
Other
- A Bachelor’s degree (or equivalent) in Statistics, Computer Science or related subject area (required), with at least 6 years of system support in clinical research within Medical Device or Pharmaceuticals
- Excellent verbal and written communication skills
- Ability to manage a project in a team environment to deliver critical milestones
- Connect – Support strategic partnerships with Clinical System and IT leaders at the Enterprise level
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs
