Jobs at Rho (rhoworld.com)

Perform onsite and remote clinical site monitoring (PSV, SIV, IMV, COV), ensure protocol and regulatory compliance, maintain audit-ready data, mentor junior staff, contribute to protocol development and RFPs, and manage relationships with clinical sites while supporting clinical operations initiatives.

Lead CMC regulatory strategy and provide tactical leadership for integrated pharmaceutical, biologic, and device development programs. Author and review CMC regulatory documents, manage budgets, timelines, vendors and deliverables, mentor staff, engage with regulatory authorities and CDMOs, identify and mitigate program risks, and support business development activities.

Maintain and enhance Excel-based pricing systems, analyze pricing requests, configure pricing logic, support proposal and contract pricing, collaborate with cross-functional teams, drive process improvements, deliver training and documentation, and ensure compliance and quality in pricing deliverables.

Lead design, development, validation, and submission of CDISC-compliant datasets (SDTM/ADaM). Author SDTM specifications, run Pinnacle 21 conformance, create define.xml and eSubmission deliverables, convert specs into SAS code, review study documents/SAPs, mentor junior programmers, act as CDISC SME, and perform functional lead activities including scope and budget oversight.

Serve as the primary administrator for NetSuite, Concur, and FloQast; manage user roles, integrations (ADP, Certinia/Salesforce, data warehouses), reporting, automations, data quality, and audit readiness. Partner with Finance, IT, and stakeholders to implement enhancements, maintain controls, provide user support/training, and document processes to ensure scalable, compliant financial systems.