ROSANGPUII S

Dynamic Sr. Clinical Research Associate with AstraZeneca Pharma India Ltd., adept in clinical trial management and effective communication. Proven track record in leading feasibility studies and managing complex projects, demonstrating agility and decision-making skills. Recognized for impactful contributions to Phase III studies and enhancing operational efficiency in clinical research.

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with Chronic Kidney Disease (DAPA -CKD), 2018-2019, Recruitment and Maintenance phase, Blinded CRA A Phase III, Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With and following Chemoradiotherapy Compared to Chemoradiotherapy Alone for Treatment in Women with Locally Advanced Cervical Cancer (CALLA), 2019-2022, SIV, Recruitment and Maintenance, Blinded CRA A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination with Standard of Care Chemotherapy and Durvalumab in Combination with Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients with Unresectable Locally Advanced or Metastatic Urothelial Cancer (NILE), 2019-2023, SIV till Interim DBL, Blinded CRA A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab as Consolidation Therapy in Patients with Locally Advanced, Unresectable, Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-Based, Chemoradiation Therapy (PACIFIC 5), 2019-2021, SIV, Recruitment and Maintenance, Unblinded CRA A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-Center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Limited Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC), 2019-2021, SIV, Recruitment and Maintenance, Unblinded CRA A Phase III Randomized, Double-Blind, Placebo-Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine plus Cisplatin versus Placebo in Combination with Gemcitabine plus Cisplatin for Patients with First-Line Advanced Biliary Tract Cancers (TOPAZ-1), 2021-2023, SIV, Recruitment and Maintenance, Unblinded CRA A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients with Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation (EMERALD-2), 2021-2023, SIV, Recruitment and Maintenance, Blinded CRA An open-label, randomized, multicenter, Phase 3 study to assess the efficacy and safety of Trastuzumab Deruxtecan as first-line treatment of unresectable, locally advanced or metastatic NSCLC harbouring a HER2 exon 19 or 20 mutations (DESTINY-Lung04), 2021-Date, Country Feasibility, SIV, Recruitment and Maintenance, Blinded CRA A phase 3, open-label, randomized study of Dato-Dxd versus investigator’s choice of chemotherapy in participants with inoperable or metastatic hormone Receptor positive, HER2 Negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy (TROPION Breast01), 2021, Study Start-up, Study Management for Startup. A Phase 2 Randomized Study of the Efficacy and Safety of Acalabrutinib with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19 (CALAVI), 2021, Country Feasibility and Initial site Selection, CRA Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINYBreast09), 2022-Till date, Recruitment and Maintenance, Blinded CRA A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination with Durvalumab and Carboplatin Versus Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Locally Advanced or Metastatic NSCLC without Actionable Genomic Alterations (AVANZAR), 2024-Till date, Recruitment and Maintenance, Blinded CRA A Phase II Study Assessing the Efficacy of Osimertinib in Combination with Savolitinib in Patients with EGFRm+ and MET+, Locally Advanced or Metastatic Non-Small Cell Lung Cancer who have Progressed Following Treatment with Osimertinib (SAVANNAH), 2024-Till date, DBL and Closeout, Blinded CRA A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination with Rilvegostomig (AZD2936) or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10), 2024-Till date, Startup & Recruitment, Study Management for Startup.

• English
• Mizo

• Performed Country level Feasibility in DESTINY Lung04 which is a Phase III interventional study on HER2 positive lung cancer.
• Performed Country level Feasibility on CALAVI Study which is a Phase III interventional study on COVID19.
• Local Study Associate Manager (Associate Project Manager) role for TROPION Breast01 study in the start-up phase (study allocation to Ready to enrol).
• Represents India in CRA Ambassador Workstream.
• Supported the LSAD in management of DESTINY Breast09 study during Ongoing phase in reconciliation and management of IEC submissions/notifications, Vendor management, Delivery of timelines for important milestones like IDMC, Interim Analysis.
• Participated as a Presenter/panelist in We Care For You - Medic Channel Knowledge Exchange which is a Platform for empowering AZ Employees in our fight against this Covid-19 pandemic along with the Medical Affairs team.