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 new ingredients, formulation changes, packaging and labelling updates.

Define data models and taxonomies for ingredient and formulation records that scale cleanly across product lines.

Cross-System Data Alignment (SAP / MDM / RIMS)

Map PLM-approved specifications and formulations to SAP Material Master data, ensuring a clean handoff from spec approval to procurement and manufacturing.





Apply MDM governance principles — golden record definitions, match/merge/survivorship rules — to ingredient and material data shared across PLM, SAP, and other systems.

Cross-check ingredient and formulation data against RIMS so regulatory status (approved/restricted by market) is reflected before formulations are finalized.

Partner with SAP, MDM, and RIMS system owners to resolve data discrepancies and maintain a single source of truth per attribute.

Business Analysis & Requirements

Lead requirements elicitation across Clinical Operations, Formulation/R&D;, Regulatory, and Quality stakeholders.

Perform fit-gap analysis for both Clinical and PLM configurations against standard platform capability.

Define functional specifications, test scripts, and UAT plans spanning both platforms.

Manage change-impact assessments and training materials across both the Clinical and PLM domains.

Required Qualifications

Experience & Core Skills

7- 8 years of experience as a Product Manager and/or Business Analyst, with genuine dual exposure to clinical systems and PLM — not just one.

Demonstrated hands-on administration of Veeva Vault Clinical - user and role management, document lifecycle and workflow configuration, and security profiles (or close equivalents)

Experience building or maintaining an ingredient/formulation database within a PLM environment.

Comfortable owning two parallel platform responsibilities and reprioritizing across both without losing depth in either.

Prior experience as an IT Business Partner or similar relationship-facing role supporting a Clinical Operations or R&D; business function.

Domain & Platform Expertise

Working knowledge of the clinical trial lifecycle (study start-up, monitoring, TMF, close-out) and key clinical roles (CRA, CTM, Data Manager).





Practical understanding of formulation/ingredient data structures — specs, BOMs, allergen, nutritional, and regulatory attributes.

Working knowledge of SAP Material Master data flow — how a PLM-approved spec becomes a procurable/manufacturable SAP material.

Understanding of MDM governance concepts — golden record, match/merge/survivorship rules — as applied to ingredient and material data.

Familiarity with RIMS and how ingredient/formulation regulatory status is tracked and enforced by market.

Solid grounding in CSV/CSA methodology and familiarity with 21 CFR Part 11 / Annex 11 requirements.

Certifications (Preferred)

Veeva Vault Clinical Business Administrator certification.

PLM Administrator / Business Administrator certification (platform-specific).

SAP MM or Agile/Scrum certification (e.g., CSPO, PSPO) is a plus.

Preferred / Nice-to-Have

Experience with adjacent clinical systems: EDC (e.g., Rave), IRT/RTSM, safety databases.

Familiarity with MDM platforms such as Informatica MDM, Reltio, SAP MDG, or Stibo.

Familiarity with RIMS platforms such as Veeva Vault RIM, EXTEDO, Ennov, or Amplexor.

Prior experience in a formulation-driven industry — pharma excipients, nutraceuticals, food & beverage, or cosmetics.

Reporting/analytics exposure (Vault Reports, Tableau, or Power BI) for cross-system dashboards.

Experience working in an Agile-hybrid delivery model within a regulated (GxP) environment.

Key Competencies

Compliance and validation discipline — CSV/CSA, 21 CFR Part 11/Annex 11, GxP

Comfortable owning two distinct platform domains in parallel without losing depth in either

Data modelling and structured thinking for ingredient/formulation taxonomies

Analytical and structured problem-solving in ambiguous, cross-functional environments

Cross-functional stakeholder management — Clinical Operations, Formulation/R&D;, Regulatory, and SAP/MDM/RIMS teams

Robust written and verbal communication — able to translate technical detail for business audiences and vice versa

Education

Bachelor's degree in Computer Science, Information Systems, or a related field; advanced degree a plus.

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