Senior R&D Digital Engineer, CTMS & Automation

Johnson & Johnson Co.; Beerse; Hybrid; EUR 73,000 - 115,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson invites applications for the Senior Engineer, R&D Digital role, located in Horsham, PA; Spring House, PA; Raritan, NJ. You will lead CTM Solutions initiatives, partner with IT and study teams, and help shape how clinical trial management systems are used across programs.

The role requires a bachelor’s degree, 5+ years in clinical trial execution, strong IT systems experience, and knowledge of GCPs and FDA CFR.

Qualifications

• Minimum of a Bachelor’s degree is required, preferably in Health, Science, Information Technology or another relevant field.
• Minimum of 5 years of relevant experience in clinical trial execution with a Pharmaceutical, Medical Device company and/or a Clinical Research Organization (CRO) is required.
• Proficiency supporting IT systems and related processes that support clinical development, reporting tools, Office 365 applications, and database administration is required.
• Solid understanding of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations is required.
• The ability to partner and influence people at all levels of the organization is required.

Responsibilities

• Identifying and implementing technology improvements that optimize CTM Solutions systems and processes and deliver measurable value.
• Assessing study-team needs and translate them into practical system and process solutions.
• Supporting study build, maintenance, and effective system use throughout the study lifecycle.
• Providing end-user support through service tickets and shared mailboxes, ensuring timely follow-up and resolution.
• Identifying and supporting opportunities to improve workflows through automation, analytics, and GenAI capabilities, while following applicable privacy, security, quality, compliance, and human oversight requirements.
• Coordinating release management, user acceptance testing, system improvements, and integrations with IT, system owners, and suppliers.
• Troubleshooting advanced system and process issues in collaboration with IT and vendors.
• Creating and delivering training, guidance, and reference materials that enable effective system and process use.
• Facilitating team meetings and contribute to cross-functional projects.
• Supporting system and process audits, regulatory inspections, and corrective and preventive actions.

Skills

Communication

Business partnering

Problem solving

Prioritization

Education

Bachelor's degree

Tools

Office 365

Database administration

SAP PLM

Job description

Johnson & Johnson invites applications for the Senior Engineer, R&D Digital role, located in Horsham, PA; Spring House, PA; Raritan, NJ. You will lead CTM Solutions initiatives, partner with IT and study teams, and help shape how clinical trial management systems are used across programs.

The role requires a bachelor’s degree, 5+ years in clinical trial execution, strong IT systems experience, and knowledge of GCPs and FDA CFR.