Lizzy J, M.A. Email & Phone Number

Stoneham, Ma, Us

Dublin , Gb

-Responsible for trial planning, execution, issue management, and all trial deliverables for assigned Merck global studies. Ensure all activities are performed in compliance with ICH-GCP, regulations, and company SOPs.-Accountable for creating and maintaining project timelines and ensure activities remain on track with escalation to appropriate stakeholders as applicable. Responsible for monitoring trial activities, tracking details/metrics, and identifying trends.-Lead and manage the cross-functional Clinical Trial Team (CTT).-Responsible for executing the protocol within the budget and ensure alignment of budget with the protocol.-Manage interactions with external vendors (e.g., IVRS, PRO, Imaging, Lab). Approve contracts, invoice payments, and change orders.-Develop and review study related manuals, plans, documents, and site communications.-Responsible for risk assessment, escalation, mitigation planning and execution.-Drive quality control and inspection readiness activities.-Maintain the Trial Master File (eTMF).-Support clinical drug supply planning.-Oversee protocol training activities.

Dublin , Gb

-Accountable for project delivery of assigned Seagen phase 1 and 2 oncology studies of increasing complexity, on time, on budget, and in compliance with all regulations and SOPs.-Leveraged phase, therapeutic area and operational expertise to advise on study activities including but not limited to site selection, activation, recruitment, vendor process, study documentation, and protocol development. Proactively identified synergies and distinctions with other trials and programs within Seagen to strive for excellence in planning and execution of study activities across the company.-Created and maintained MS Project and Planisware timelines for more intricate studies.-Continued to lead clinical trial team meetings and ensured cross-functional follow up as required. Navigated competing priorities across multiple functional areas.-Monitored study metrics, identified trends for attention, and advanced the implementation of strategies to address findings. Escalated issued to management and/or leadership as required.-Generated project budgets. Responsible for enrolment projections and anticipated drug supply needs.-Oversaw increasing numbers of clinical trial vendors (CRO, IVRS, imaging, recruitment, subject reimbursement, ancillary supplies, meeting planning etc.), including vendors not previously used by the company. Activities included establishing services/processes, updating contract scope, monitoring engagement/performance, reconciling invoices against study contracts, and monitoring spend.-Drove and conducted risk management/mitigation training and discussions. Supported inspection readiness activities, identified and contributed to areas of best practice, and made recommendations for process improvement within the company as well as vendors contracted to support Seagen studies.-Authored high quality reports for management and leadership on program status and issues.-Mentored and supported Clinical Project Managers (ICON and Seagen).

Dublin , Gb

-Responsible for project delivery of assigned Seagen phase 1 and 2 oncology studies, on time and on budget. Managed study conduct to timeline completion in compliance with all regulations and SOPs. -Advised on study activities including but not limited to site selection, activation, recruitment, vendor process, study documentation, and protocol development. Actively identified synergies and distinctions with other trials and programs within the company to strive for excellence in planning and execution of study activities.-Led clinical trial team meetings and performed cross-functional follow up. Negotiated and managed competing priorities across multiple functional areas.-Produced and maintained MS Project and Planisware timelines, using these timelines to track and manage a project’s progress.-Oversaw study metrics, identified trends for attention, and implemented strategies to address them. Worked in close collaboration with functional teams to review and implement strategies in order to address findings. Escalated issues as needed.-Created project budgets and managed costs to budget. Developed enrolment and drug supply projections.-Managed and coordinated all clinical trial vendors (CRO, IVRS, imaging, recruitment, subject reimbursement, ancillary supplies, meeting planning etc.). Activities included establishing services /processes, updating contract scope, monitoring engagement/performance, reconciling invoices against study contracts, and monitoring spend.-Led risk management/mitigation discussions and supported inspection readiness activities, identified and contributed to areas of best practice and made recommendations for process improvement. Participated in quality investigations.-Prepared high quality reports for management on program status and issues.-Supported ICON in the hiring and mentoring of Clinical Project Managers embedded at Seagen.

- Managed all clinical aspects of TCR2’s lead phase 1/2 cell therapy clinical trial in the oncology therapeutic space. Assessed operational feasibility and recommended study execution plans; managed study timelines, milestones and metrics; participated in selection and oversight of external vendors; reviewed vendor reports, budgets, and metrics; data and safety management; conducted study-specific training and led clinical research staff. - Provided operational input and subject matter expertise to design clinical trial protocols and support regulatory filings, including review and quality control of protocol amendments, DSURs, Investigator's Brochure updates and Clinical Trial Applications. Coordinated and assisted in the planning of regulatory and ethics committee activities.- Prepared/reviewed/approved study-related documents and plans (e.g., monitoring plan, laboratory manual, CRF and CRF completion guidelines, informed consents, budgets and contracts); tracked status of documentation through to full execution.- Ensured clinical trial execution in compliance with ICH/GCP guidelines, regulations and applicable SOPs; participated in quality assurance activities and coordinated resolution of audit findings; reviewed monitoring reports to ensure quality and resolution of site-related issues. - Led review of protocol deviations, identified trends and strategies for resolution. Proactively identified risks, implemented and tracked mitigation strategies.- Frequently interfaced with cross-functional teams ensuring project team alignment on major milestones and deliverables. Communicated and presented project status, complex issues, and study accomplishments to management and stakeholder groups.

Cambridge, Massachusetts, Us

- Involved in the planning, implementation, and oversight of AVROBIO’s lead multi-national phase I/II lentiviral gene therapy study and the associated long term follow up study, in a rare disease therapeutic area. Ensured efficient and timely execution of the clinical trial in compliance with ICH/GCP guidelines, regulations, and SOPs.- Managed CRO and clinical vendor activities, ensuring study execution was conducted in accordance with the approved study plans, and timelines. Developed and reviewed study plans including project management, safety management, and monitoring plans. Assisted in critically evaluating proposals, contracts, and change orders. Created protocol training materials, and conducted CRO/vendor training.- Played a key role in the creation and review of data management plans, case report forms, and corresponding completion guidelines. Participated in EDC development (initial concept, UAT, edit-checks, mid-study updates). - Contributed to data and safety review meetings to identify issues, determine appropriate action, and ensure follow up to resolution. Monitored the status of clinical data collection at the sites.- Reviewed draft protocols and amendments, providing feedback prior to finalization. Participated in country (US, Canada and Australia), and site-level regulatory submissions. Developed, reviewed, and revised master and site specific ICF templates. - Identified and selected investigator sites, ensured strong relationships with the study teams were established and maintained. Oversaw study start up processes, including budget negotiation, contract finalization and regulatory submissions. Reviewed clinical monitoring reports, and correspondence related to monitoring visits, escalated issues, as appropriate. Participation in site visits, including training of study staff.- Provided timely updates and study metrics to key stakeholders. Led and motivated internal and external cross-functional teams to achieve the study targets.

Us

- Managed 12 Phase II and III industry sponsored dermatology/rheumatology clinical trials, supporting multiple Principle Investigators to ensure project deadlines and targets were achieved. - Independently managed study recruitment, study visits and procedures, data and safety reporting, regulatory submissions, patient reimbursement, Investigator Site File maintenance, and facilitated CRO or sponsor visits.- Ensured compliance to study protocol and ICH/GCP; Experience facilitating sponsor GCP compliance audits.

Us

- Performed Cutaneous T-Cell Lymphoma (CTCL) translational research resulting in 5 journal and 15 abstract publications. Primary liaison between the research and clinical teams, prepared/delivered reports to multidisciplinary teams, managed vendors, created and managed the sample database, trained/supervised staff and collaborators.

Boston, Ma, Us

Performed DNA damage response research that led to a publication in Mol Cell.

Us

Studied Epstein Barr virus proteins and how they contribute to lymphoproliferative disorders, contributing to a publication in PNAS.

Oxford, Oxfordshire, Gb

Studied the effect of common breast cancer drugs on ErbB4/HER4 expression in breast cancer cell lines.

London, Gb

Master Of Arts (M.A.), Molecular Medicine

Bachelor Of Arts (Moderatorship), Molecular Medicine