Shreya Shirodkar Email & Phone Number

Boston, Ma, Us

United States

Cambridge, Massachusetts, United States

Worcester, Massachusetts, United States

India

• Provided guidance to the Clinical Trial teams (CTT) regarding efficient strategies for clinical trial supply, packaging design, technical and timeline feasibility, efficiency, and risk management. • Ensured completion and accuracy of clinical supply demand in alignment with protocol requirements, key study parameters and milestones, and patient projections. This was achieved with appropriate overage and by following defined processes and systems.• Created and finalized the packaging design (Clinical Packaging Request) and developed a comprehensive label strategy for all participating countries in the clinical trial. • Identified, assessed, and proactively communicated supply risks to all relevant team members, accompanied by mitigation strategies to ensure continuous supply. • Collaborated with all line function partners to establish optimal supply strategies based on country submission approval timelines. • Consolidated, maintained, and tracked the clinical trial budget with key stakeholders, encompassing overall external costs for GCS (e.g., labels, packaging, distribution, and comparators). • Utility of tools like SAP for supply management/planning and IRT systems in clinical distribution at the site was leveraged. • Played an active role as a full member in the GCS sub-team, facilitating the exchange of relevant knowledge and information between the GCS sub-team and the CTT in a proactive manner.

Hyderabad Area, India

• Managed all technical and operational aspects of the Novartis Interactive Response Technology (NIRT); a Novartis 'Crown Jewels' system, considered vital to the organization for recording patient data related to randomization and drug dispensation.• Led completion and approval of Parameter Sheet/URS for study systems, translating IRT needs (per protocol) into high-quality development of NIRT system. • Managed technical aspects of system lifecycle (SLC), leading configuration and validation of NIRT system (in collaboration with External Service Provider) through setup and "Go-Live." • Engaged in problem-solving and resolution efforts by assisting with issue identification, resolution, documentation, and escalation (NIRT super user, driving root cause analysis of system and site issues). • Communicated and coordinated with stakeholders within and across the global project to identify areas for further standardization, alignment, and improvements. • Produced and distributed status, tracking, and key reports for internal and external team members and senior management.• Performed UAT(User Acceptance Testing) for system enhancements and new features in NIRT.Important achievements in this role - 1. Handled implementation of chat tool on the system to reduce the ticket size and increase TAT and overall efficiency of the system. 2. Building interactive training materials for the system with "Articulate 360"3. Working on system enhancement with the BAs from idea generation to execution support and testing.

Hyderabad Area, India

• Worked on GCS Supply Chain strategy of finished clinical kits planning, Clinical Supply & Operations Planning (CS&OP), Long Term Demand and Capacity Planning, Shelf-life management, and financial planning. • Interpretation of clinical protocol, study design, generated demand forecast, Distribution plan, IRT Setup, and Resupply planning • Gained exposure to GMP/GCP and GDP environments along with audit experiences. • Executed and monitored timely activities related to trial/project management in GCS under the guidance and accountability of senior associates.

Ms In Operations And Supply Chain Analytics, Operations Management, Supply Chain Management And Analytics

Master Of Business Administration - Mba, Marketing And Operations

Bachelor Of Engineering (Beng), Information Technology

B.E in Information Technology