Role Summary
This role supports the R&D; data foundation — owning the formulation and ingredient database in PLM, building out the ingredient and formulation data structures that R&D; and downstream systems rely on and keeping it aligned with SAP (Material Master), MDM (golden record governance), and RIMS (regulatory status by market) — while also supporting Clinical Operations as an IT Business Partner. As the Clinica Product Manager the role acts as the trusted point of contact for Clinical Operations on their day-to-day system’s needs.
Key Responsibilities
Clinical Systems Ownership & Business Partnering
Be the trusted IT Business Partner for Clinical Operations — understanding their day-to-day challenges and priorities and acting as the go-to point of contact for anything system-related.
Manage product backlog, roadmap delivery and documentation, and track adoption. Point of contact for vendors and implementation partners.
Support the clinical trial lifecycle — study start-up, site activation, TMF management, monitoring, and study close-out — within Vault Clinical (eTMF, CTMS,



SSU).
Coordinate integrations between Vault Clinical and adjacent systems (EDC, IRT/RTSM, safety databases) via Vault Connections and APIs as required.
Serve as the escalation point for Clinical Operations on system issues, ensuring business impact is understood and addressed with the right urgency, Partner with the ITSM team to manage incident, problem, and change management processes (e.g., ServiceNow) for the platform, ensuring SLAs are met.
PLM & Formulation/Ingredient Database
Support design, build, and maintenance of the formulation and ingredient database in PLM — specifications, BOM/recipe structures, allergen and regulatory attributes, and ingredient hierarchies.
Own change control (ECR/ECO) for current ingredients, formulation changes, packaging and labelling updates.
Define data models and taxonomies for ingredient and formulation records that scale cleanly across product lines.
Cross

📌 R&D Data Analyst (Hyderabad)
🏢 Opella
📍 Hyderabad