Anviti Vyas
London,England
Summary
Accomplished Global Clinical Trial Leader with 11 years’ experience in global study management, including 3 years’ of direct line management.
Demonstrated success in leading the delivery of complex programs while adept at building and fostering high-performing teams within matrix organizations with strong problem-solving, communication and leadership abilities. Committed to driving projects to successful completion, delivering impactful results for stakeholders.
TA Experience:
- Oncology + Early phase: Lung Cancer (III), Triple Negative Breast Cancer (III), Pancreatic Cancer (II), Solid Tumors (I), Adaptive trial model, Platform studies, Basket trials (Phase 1 and Phase 2).
- Rare genetic subtype Oncology: BRCA1 and BRCA2 genes, TNBC, JAK2 in MDS
- Haematology: AML (II, III: Platform/rollover adaptive trail), 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)
Overview
12
12
years of professional experience
5
5
years of post-secondary education
Work history
Senior Global Project Lead/ Sr. Study Start-Up Lead
ProPharma Group
London
03.2024 - 07.2025
- 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).
- Provide strategic direction and operational oversight for multiple concurrent studies, ensuring quality and performance measures are met.
- Influence cross-functional teams and senior stakeholders for crucial decision making keeping patient safety, data integrity, study timeline and budget at core.
- Drive strategic decision-making through risk assessment and proactive mitigation, ensuring inspection readiness and data integrity.
- Participate in Bid Defense preparation and delivery, contributing to business growth and client relationship management.
- Lead vendor contract execution (RFP to contract approval) and in-life management of vendors.
- Lead development and delivery of clinical study budgets, timelines, and resource management, with focus on quality and operational strategies to support study objectives.
- Lead global study teams: hiring, mentoring and fostering agile team culture.
- Lead technical and operational aspects of country/site identification, site feasibility, site activation, global recruitment/retention, site/study close-out for assigned projects, site contracts, and project teams.
- Lead development of study-level documents; protocol (writing/amendments), master ICF, IB, plans and obtaining rapid approval from ethics committees and local regulatory authorities.
- Lead contracts/Budget negotiation (Country/ Site/ vendors) in collaboration with Legal team, as required and ensure compliance with Fair Market Value (FMV) in country.
- Lead and prepare SOPs, process development and flow charts to train global cross-functional teams.
- Lead global Data management for primary/interim analysis, and final database lock.
- Conducted regular review meetings to assess progress against planned activities and timelines.
- Identified potential challenges with strategic planning and proactive problem-solving approaches.
- Facilitated open communication channels within team, fostered positive work environment.
Senior Clinical Trials Manager
Gilead Sciences Inc.
London
01.2022 - 01.2024
- Global end-to-end clinical trials management + Line Management
- Study: Oncology- i) Phase III, early start-up, double-blinded, Myelodysplastic Syndrome. ii) Phase I, evaluating safety and tolerability of immunomolecule in advanced solid tumors. iii) Phase III TNBC, early start-up, double-blinded, iv) Phase 3 lung cancer- Neoadjuvant, early start-up (feasibility and site selection), open-label.
- Line management of direct line reports; supporting career progression, appraisals, and annual reviews.
- Led data cleaning activities for primary/interim analysis and final database lock while adhering to study timelines.
- Led global patient recruitment and retention strategies.
- Led unblinded safety queries along with clinical scientists.
- Led preparation and submission of Protocol writing, amendment, regulatory core pack to ethics and regulatory adhering to timelines.
- Led end-to-end clinical trial cycle: Study start-up, Country/site selection, feasibility, PSSV, SIV, country/site activation, study maintenance and close out along with CSR/LFT submissions.
- 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 level contract, budget, forecasting and accruals vs study level budget.
- Led CRO regional CTMs and supported them in resolution of country escalation issues.
- Involved in preparing RFP and vendor/CRO selection while training teams for CRO excellence strategies.
- Led and presented in IM.
- Led preparation of investigator brochures, presentations, newsletters, storyboard, and patient cards.
- Led, delegate, manage or prepare study level plans, train study team for process development, etc. at global level.
- Managed risk assessment and develop risk mitigation strategies to support study delivery.
- Managed communication of strategy and rationale for enabling decisions to CST/SMT.
Global Clinical Trials Manager
AbbVie Inc.
Maidenhead
03.2020 - 12.2021
- Oncology, Adaptive model (Roche and BMS): Phase IIb in loop of Phase III AML study (Venetoclax).
- Led study recruitment, data management, retention, study plan, timelines (using Project Planner), protocol amendments, implementation, and process development.
- Led EMEA, LATAM and APAC region for country/site selection and initiation, contract execution, and approval of site greenlight after IEC/IRB approval.
- Led vendor contract execution (RFP to contract approval) and in-life management of vendors (IXRS, central lab vendors, equipment vendors).
- Led CRO for operational oversight, contract and budget amendments and RA/EC submissions.
- 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, trained sites, presented in Investigator meetings, SEV training meetings etc at global level.
- Managed project lifecycle including initiation, maintenance and study close-out activities including TFL and CSR preparation at global level.
- Managed Regional Site Managers/CRAs and ensure TMF is maintained for inspection readiness.
- Managed MTAs and export permits for specific countries as per country’s material transport regulations.
- Managed risk assessment and developed risk mitigation strategies including Key Risk Indicators to support study delivery.
- Managed communication of strategy and rationale for enabling decisions to CST/SMT.
- Managed identification, resolution, and escalation of issues.
Global Studies Manager
Roche Products Limited
Welwyn Garden City
07.2019 - 02.2020
- Oncology: TNBC (phase III) and Pancreatic Cancer (Phase II)
- Led multiple global recruitment/retention, trend analysis and prepared mitigation strategies.
- Led CROs and vendors (IXRS, central labs) to ensure delivery against contracted scope of work.
- Led delivery of Sunshine Act review for data analysis and inspection readiness.
- Led study-level system development SIP (Shared Investigator Platform) for better communication with sites.
- Managed and prepared study plans, budget, risk, IM activities, and timelines and provided clinical expertise to ensure operational feasibility and delivery.
- Managed study-level conduct of clinical trials from design to closeout and identified areas of best practice.
- Managed issue identification and escalation to higher management.
- Ensured study adherence to ICH/GCP, SOPs and TMF management.
Senior Clinical Trials Manager Associate
Gilead Sciences Inc.
London
07.2018 - 07.2019
- Managed CRO and vendors along with contract and invoice execution.
- 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/Project Manager (Global)
Docs Global Inc./ICON Plc for Amgen Inc.
Marlow
03.2016 - 07.2018
- Clinical Trials management by leading country management to support Regional and global study manager.
- Supported management of vendors whilst adhering to protocol timelines.
- Proactively resolved issues/queries, prepared tools and trackers and maintained TMF.
- Performed co-monitoring activities and participated in site evaluation and initiation tasks.
- Received multiple ‘Inspiration’ awards on recommendation from Amgen for providing continued support outside my direct responsibilities to help achieve important goals and milestones.
Research Scientist/ Site Coordinator
Kennedy Institute of Rheumatology, University of Oxford
Oxford
04.2014 - 02.2016
- Preclinical trials on Rheumatoid Arthritis, Neuroimmunology and Psychiatry (Major Depressive disorder).
- Wellcome trust-funded BIODEP Project: laboratory set-up, management and laboratory analysis.
- https://www.psych.ox.ac.uk/news/oxford-key-host-for-wellcome-consortium-on-depression
- Developed and optimised high throughput immunology and genetic techniques for clinical laboratory research to study BIODEP evaluation on whole blood pool of patients using mRNA, qPCR, gel electrophoresis and FACS technologies.
- Worked as site coordinator at Oxford University Hospital as part of BIODEP study.
- Managed SOPs compliant with COSHH to carry out risk assessments for experimental protocols.
Research Assistant
London School of Hygiene and Tropical Medicine
London
09.2013 - 03.2014
- Worked on high throughput immunology and Microbiology research on infectious diseases (pathogenic E. coli).
- Designed and planned research protocol and research document according to GCLP.
- Maintained lab infrastructure, prepared and edited grant papers, and presented lab research.
Education
M.Sc. - Immunology of Infectious Diseases
London School of Hygiene and Tropical Medicine
London 07.2012 - 09.2013
M.Sc. - Microbiology (Hons.)
Veer Narmad South Gujarat University
Surat, India 07.2007 - 04.2009
B.Sc. - Microbiology
Veer Narmad South Gujarat University
Surat, India 07.2007 - 04.2009
Skills
Core Skills: Collaborate, Innovate, and Drive operational excellence
Global clinical trial leadership: (Phase I–III, adaptive/platform studies)
Cross-functional & Matrix team management
Stakeholder engagement & Communication
CRO and Vendor oversight & negotiation
Budget and Timeline Preparation & Management
Regulatory submissions & compliance (IRB/IEC/IRAS/HREC/HCAN/CTR)
Risk Assessment & Mitigation
SOP/Process development & improvement
Line management & team development
Proficient with MS Planner, Gantt Charts, MS Forms, Smartsheet, Excel and Grant Management systems
Languages
English
Fluent
Hindi
Native
Affiliations
- Play Sitar, travel, scuba dive, salsa dance, paint, and teach painting to children
Accomplishments
- 'Standing oviation' at Propharma group for devlivering start-up activities within the planned timeline for phase II IPF study.
- Multiple 'recognision' awards at Gilead for 'CRO excellence management', Phase 3 AML study primary, interim and final database 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.
Timeline
Senior Global Project Lead/ Sr. Study Start-Up Lead
ProPharma Group
03.2024 - 07.2025
Senior Clinical Trials Manager
Gilead Sciences Inc.
01.2022 - 01.2024
Global Clinical Trials Manager
AbbVie Inc.
03.2020 - 12.2021
Global Studies Manager
Roche Products Limited
07.2019 - 02.2020
Senior Clinical Trials Manager Associate
Gilead Sciences Inc.
07.2018 - 07.2019
Senior Associate Study/Project Manager (Global)
Docs Global Inc./ICON Plc for Amgen Inc.
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 and Tropical Medicine
09.2013 - 03.2014
M.Sc. - Immunology of Infectious Diseases
London School of Hygiene and Tropical Medicine
07.2012 - 09.2013
M.Sc. - Microbiology (Hons.)
Veer Narmad South Gujarat University
07.2007 - 04.2009
B.Sc. - Microbiology
Veer Narmad South Gujarat University
07.2007 - 04.2009
Similar Profiles
Jessica LuvianosJessica Luvianos
Central Study Coordinator at ProPharma GroupCentral Study Coordinator at ProPharma Group
Carrie SlaughterCarrie Slaughter
Billing Specialist at Propharma GroupBilling Specialist at Propharma Group
Hana WaheedHana Waheed
Pharmacovigilance Specialist at ProPharma GroupPharmacovigilance Specialist at ProPharma Group
Abiodun AdeolaAbiodun Adeola
Family support worker at Mr JosephFamily support worker at Mr Joseph
Melvin CohenMelvin Cohen
Sales account executive at Bloomberg LPSales account executive at Bloomberg LP