Senior Engineer, R&D Digital

h3Purpose: /h3pThe Senior Engineer, RD 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. /ppThe 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. /ph3You will be responsible for: /h3ulliIdentifying and implementing technology improvements that optimize CTM Solutions systems and processes and deliver measurable value. /liliAssessing study-team needs and translate them into practical system and process solutions. /liliSupporting study build, maintenance, and effective system use throughout the study lifecycle. /liliProviding end-user support through service tickets and shared mailboxes, ensuring timely follow-up and resolution. /liliIdentifying and supporting opportunities to improve workflows through automation, analytics, and GenAI capabilities, while following applicable privacy, security, quality, compliance, and human oversight requirements. /liliCoordinating release management, user acceptance testing, system improvements, and integrations with IT, system owners, and suppliers. /liliTroubleshooting advanced system and process issues in collaboration with IT and vendors. /liliCreating and delivering training, guidance, and reference materials that enable effective system and process use. /liliFacilitating team meetings and contribute to cross-functional projects.
Supporting system and process audits, regulatory inspections, and corrective and preventive actions. /li /ulh3Qualifications /

Requirements:
/h3ulliMinimum of a Bachelor’s degree is required, preferably in Health, Science, Information Technology or another relevant field. /liliMinimum 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. /liliProficiency supporting IT systems and related processes that support clinical development, reporting tools, Office 365 applications, and database administration is required. /liliSolid understanding of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations is required. /liliThe ability to partner and influence people at all levels of the organization is required. /liliSuperior communication, business partnering, problem solving, and prioritization skills is required. /liliGlobal business mindset is required. /liliAbility to travel up to 10% of the time (Domestic/International) is required. /liliProject Management or Process Improvement certification is preferred. /li /ulh3Preferred

Skills:
/h3pAnalytical Reasoning, Critical Thinking, Data Savvy, Digital Fluency, Digital Strategy, Engineering, Product Design, Product Development, Product Improvements, Product Portfolio Management, Report Writing, Research and Development, Safety-Oriented, SAP Product Lifecycle Management, Statistics, Technical Credibility, Technologically Savvy /p