Senior Engineer, R&D Digital

Purpose

The Senior Engineer, R&D Digital provides expertise and executes plans for Clinical Trial Management Solutions (CTM Solutions) systems and processes. The role supports capabilities for clinical trial study management and oversight solutions including CTMS, Site Payments and Access Provisioning. Under general direction, this role executes plans and processes that innovate product development, meet organization standards, and follow digital strategy. This role is a liaison between the business community and key partners and stakeholders. The Senior Engineer collaborates with business partners, IT, and suppliers and contributes to customer enablement, metrics, user administration and support, system integrations, continuous improvement, and change management.

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.

Qualifications / Requirements

• 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.
• Superior communication, business partnering, problem solving, and prioritization skills is required.
• Global business mindset is required.
• Ability to travel up to 10% of the time (Domestic/International) is required.
• Project Management or Process Improvement certification is preferred.