ANVITI VYAS
London,UK
Summary
Accomplished Global Clinical Trial Leader with 11 years of experience in global study management and 3 years of direct line management with strong problem-solving, communication and leadership abilities. Experienced in delivering complex programs from study set-up through close-out, encompassing strategic planning, CRO/vendor oversight, and cross-functional leadership, while ensuring data integrity, regulatory compliance, and patient safety. Skilled in developing study timelines, budgets, CTMS/EDC/IXRS/RBM setup, KPIs, and risk mitigation strategies. Recognized for consistently exceeding enrollment targets, accelerating site activations, achieving database locks, fostering high-performing teams within matrix organizations, and driving operational excellence to deliver impactful results for stakeholders.
Proficient in RAVE Grant Management MEDIDATA, MS 365 apps: Excel/ Project Planner, Gantt Chart, SmartSheet, Visio.
TA Experience:
Phase I, Phase II (dose-finding, Cohort) and Phase III
• Oncology + Early phase: Non-small cell lung cancer- NSCLC (III), Triple Negative Breast Cancer (III), Pancreatic Cancer (II), Solid Tumors (I) • Rare genetic subtype Oncology: BRCA1 and BRCA2 genes, TNBC, JAK2 in MDS
• Hematology: AML (II, III: Platform/rollover adaptive trial), MDS (III)
• Immunology/Genetic/ Rare Disease: Prurigo Nodularis (II), Idiopathic Pulmonary Fibrosis (II)
• Gastroenterology: Diabetic Gastroparesis (II), Liver Diseases: NASH (III)
• Cardiovascular: Hyperlipidemia (Phase III), Heart Failure (III)
• Metabolic Diseases: Type 2 Diabetes and Obesity (II)
• Musculoskeletal: Rheumatoid Arthritis (I)
Awards:
- 'Standing ovation' at Propharma group for delivering start-up activities within the planned timeline for phase II IPF study.
- Gilead & Abbvie: Multiple 'recognition' awards at Gilead for 'CRO excellence management', Phase 3 AML study primary, interim and finaldatabase lock, Phase 3 AML study recruitment target achieved before the timeline.
- Multiple ‘Inspiration' awards at Amgen for providing continued support outside my direct responsibilities to help achieve important goals and milestones.
Overview
12
12
years of professional experience
Work History
Senior Global Project Lead, Senior Study Start-up Lead
ProPharma
03.2024 - Current
- Lead multiple global Immuno-Oncology & rare diseases phase I/II studies, overseeing study design, start-up, and operational delivery (end-to-end clinical trial delivery).
- Influenced cross-functional teams and stakeholders in strategic decision-making through key risk assessment, trend analysis and proactive risk mitigation.
- Led study management team meetings providing mentoring to drive alignment, develop talent, and ensure effective study delivery.
- Facilitated open communication channels within the team and fostered a positive, collaborative work environment.
- Baseline study timeline and budget development and maintenance.
- Lead Country/Site/vendor contract and budget development, negotiation and oversight with forecasting and accruals against the study budget.
- Participate in RFP writing and Bid Defense meetings, contributing to business growth and client relationship management.
- Lead global study teams: hiring, mentoring, annual review and fostering agile team culture.
- Lead technical and operational aspects of country/site selection, feasibility, site activation, global recruitment/retention and site/study close-out.
- Lead development of study-level documents; protocol (writing/amendments), master ICF, IB, plans and obtaining rapid approval from FDA/IND, IEC, IRB and local regulatory authorities.
- Lead global Data management for primary/interim analysis, and final database lock.
Senior Global Clinical Trials Manager + Line Management
Gilead Sciences
01.2022 - 01.2024
- Oncology: i) Phase III, early start-up, Myelodysplastic Syndrome. ii) Phase I, advanced solid tumors. iii) Phase III TNBC, early start-up. iv) Phase III Non-small cell lung cancer, Neoadjuvant, early start-up, open-label.
- Line management of direct line reports; supporting career progression, appraisals, and annual reviews.
- Led preparation and submission of Protocol/amendments, regulatory core pack to ethics and regulatory adhering to timelines and presented in study management meetings.
- Led data cleaning activities including unblinded queries and PDs/IPDs for primary/interim analysis and final database lock while preparing CSR and TFLs.
- Led global patient recruitment and retention strategies, achieving enrollment 10 days ahead of target.
- Led CRO/vendor contract execution (RFP to contract approval) and in-life management of vendors (IXRS, central lab vendors, equipment vendors).
- Led Country/CRO/vendor budget development, forecasting and accruals, Invoice, SOW and CO approvals.
- Led vendor close-out for underperforming vendor saving 10% total study budget.
- Led oversight of CRO regional CTMs and supported them in resolution of country escalation issues.
- Represented the study team during audits and inspections, responding to auditor inquiries, preparing and submitting CAPA reports to ensure compliance.
- Led Management of TMF for inspection readiness.
- Training teams for CRO excellence strategies for fully outsourced studies.
- Led study level plans, process development, newsletters, storyboard, SOPs etc. at global level.
- Led developing KPIs and risk mitigation strategies to support study delivery.
- Led communication of strategy and rationale to CST/SMT to enable decision-making.
Global Clinical Trials Manager- Contract
AbbVie
03.2020 - 12.2021
- Adaptive Trial model (Roche and BMS), In-house Oncology: Phase IIb in loop of Phase III AML study (Venetoclax).
- Study timeline and budget development, country/site selection, feasibility and activation including contract and budget negotiation and execution.
- Led study recruitment, data management, retention, study plan, timelines, protocol amendment, implementation, and process development.
- Led vendor contract execution, UAT and in-life management (IXRS, central lab, equipment vendors).
- Led budget forecasting for country and vendors, preparing accruals and invoice approvals.
- Led patient's slot allocation for dose-finding (drug dossier design - dose escalation, reduction, and safety expansion) cohorts for competitive recruitment.
- Led and prepared study-level plans, presented in IM, SEV/SIV training meetings, etc., at the global level.
- Managed regional site managers/CRAs for country/ Site management, monitoring report review, PD/IPD review and ensured TMF is maintained for inspection readiness.
- Managed MTAs and export permits for specific countries as per country's material transport regulations.
- Developed risk assessment and risk mitigation strategies, key risk indicators to support study delivery.
- Managed communication of strategy and rationale for enabling decisions to CST/SMT.
Global Studies Manager- Contract
Roche
07.2019 - 02.2020
- Managed end-to-end conduct of phase II/III clinical trials for TNBC and Pancreatic Cancer, ensuring adherence to ICH/GCP, SOPs, protocol timeline and budget, and TMF management.
- Led global recruitment/retention strategies and trend analysis, devising effective mitigation strategies to enhance trial efficiency.
- Managed CROs and vendors, including IXRS and central labs, ensuring delivery aligns with contracted SOW and operational feasibility.
- Oversaw development of the Shared Investigator Platform (SIP), improving site communication and study level system integration.
- Executed Sunshine Act review, enhancing data analysis and maintaining inspection readiness.
- Developed and managed comprehensive study plans, storyboards, flow charts and tools.
- Facilitated issue identification and escalation to senior management with proposed resolution.
Senior Clinical Trials Manager Associate- Contract
Gilead Sciences
07.2018 - 07.2019
- Managed global regions, CRO and vendors while overseeing contracts and invoices for pivotal phase 3 NASH clinical trial.
- Managed monitoring visits, visit reports, CRA, study feasibility/contracts, risks, TMF completeness, functional QC and close-out activities (COV, DBL).
- Performing Data Line Listing Review for Data Cleaning activities to raise queries on EDC/RAVE.
- Supervised Ethics Committee submission; followed up EC queries and amendments.
- Managed preparation and updates of ICF, study plans, recruitment materials and training materials.
- Worked closely with CRA to follow up on safety (SAE/AE) and resolved data discrepancies.
- Carried out audit report review and prepared lessons learnt (CAPA), collaborated in regulatory inspections (MHRA) and ensured inspection readiness was maintained by sponsor and CRO.
Senior Associate Study
Amgen/ICON DOCS
03.2016 - 07.2018
- Phase 3 Cardiovascular and Phase 2 Oncology studies.
- Prepared excel tools for data trend analysis.
- Supported management of vendors whilst adhering to protocol timelines and budget.
- Conducted co-monitoring and participated in site evaluations and initiations to maintain study quality.
- Resolved country and site-level issues proactively with proposed solutions and maintained TMF accuracy.
Research Scientist/ Site Coordinator
Kennedy Institute of Rheumatology, University of Oxford
04.2014 - 02.2016
- Preclinical trials on Rheumatoid Arthritis, Neuroimmunology and Psychiatry (Major Depressive disorder).
- Developed and optimized high-throughput immunology and genetic techniques (mRNA, qPCR, electrophoresis, FACS) for clinical research.
Research Assistant
London School of Hygiene & Tropical Medicine
09.2013 - 03.2014
- Worked on high throughput immunology and Microbiology research on infectious diseases (pathogenic E. coli)
Education
M.Sc. - Immunology of Infectious Diseases
London School of Hygiene & Tropical Medicine
London, UK09.2013
M.Sc. (Hons.) - Microbiology
Veer Narmad South Gujarat University
Surat, India, India04.2009
B.Sc. - Microbiology
Veer Narmad South Gujarat University
Surat, India, India04-2007
Timeline
Senior Global Project Lead, Senior Study Start-up Lead
ProPharma
03.2024 - Current
Senior Global Clinical Trials Manager + Line Management
Gilead Sciences
01.2022 - 01.2024
Global Clinical Trials Manager- Contract
AbbVie
03.2020 - 12.2021
Global Studies Manager- Contract
Roche
07.2019 - 02.2020
Senior Clinical Trials Manager Associate- Contract
Gilead Sciences
07.2018 - 07.2019
Senior Associate Study
Amgen/ICON DOCS
03.2016 - 07.2018
Research Scientist/ Site Coordinator
Kennedy Institute of Rheumatology, University of Oxford
04.2014 - 02.2016
Research Assistant
London School of Hygiene & Tropical Medicine
09.2013 - 03.2014
M.Sc. (Hons.) - Microbiology
Veer Narmad South Gujarat University
M.Sc. - Immunology of Infectious Diseases
London School of Hygiene & Tropical Medicine
B.Sc. - Microbiology
Veer Narmad South Gujarat University