Collaborate with Product team to own the end-to-end lifecycle for core clinical development systems (~10 systems including IRT/RTSM, EDC, Medical Review, CTMS, eTMF, PV database, statistics & analysis platform, Data Room, project management, eCOA/ePRO).
Defines product vision, strategy, and roadmap aligned to clinical development objectives, compliance requirements, and user experience; establishes OKRs/KPIs for value realization.
Leads demand intake and prioritization with business stakeholders; makes product decisions and trade-offs to maximize patient safety, data integrity, delivery predictability, and total cost of ownership.
Understands end-to-end clinical R&D processes and anticipates evolving needs (e.g., decentralized trials, real-time data review, automation, and analytics enablement).
Defines and monitors product metrics (adoption, incident/defect trends, system performance/availability, cycle time).
Drive continuous discovery with Clinical Ops to uncover pain points and translate them into requirements, user stories, and solution options.
Maintains a prioritized backlog and release plan; owns cross-system dependency management and end-to-end integration delivery.
Drives user adoption and change management: training enablement, communications, SOP/process updates.
Leads release, validation/compliance, and support planning to ensure stable operations and inspection readiness.
Acts as the primary interface between business stakeholders, IT delivery/operations, and external vendors; facilitates clear communication, issue resolution, and timely decisions.
Manages product financials and vendor contracts; continuously optimizes operating model and total cost of ownership.
Ensures fit-for-purpose governance and documentation in partnership with QA/Compliance and IT.
Requirements
Fluent English as working language (written and spoken); able to communicate effectively with global teams and vendors.
Strong presentation and stakeholder communication skills; able to synthesize complex topics and drive decisions with cross-functional audiences.
Pharma R&D statistics and analysis literacy—clinical trial data concepts, data review/analysis readiness, and ability to translate analysis needs into system/product requirements.
Clinical development domain knowledge across the study lifecycle (protocol to database lock to safety reporting) and understanding of how clinical systems support delivery.
Basic awareness of compliance in clinical development, including GCP principles and computerized system validation (CSV) / GxP requirements.
Requirements, process & change management experience in a regulated environment.