Leila Cupersmith Email & Phone Number

United States

Provide strategic clinical trial operations consultation services for pharmaceutical and biotechnology global oncology clinical trials, from planning through close-out, ensuring successful, within budget completion across phases 1 through 3. Inclusive of the following services:- CRO/Vendor Selection, Contract Negotiations, and Management- Portfolio, Program and Project Management and Execution: Global trial coordination, Timeline and budget management, Risk mitigation and management, Study plan writing, SOP writing, Decentralized Clinical Trial (DCT) strategy design, implementation and management.- Data Management: Data strategy development, Provide strategic oversight of interim analyses, sweeps and locks, Support data monitoring committees setup and management- Quality Assurance and Compliance: GCP compliance, Audit preparation, Support development of quality management system- Patient Recruitment and Retention: Strategy development, Protocol and site-specific patient pathway development, Site and PI selection and engagement, Patient engagement- Global Operations and Logistics: Supply chain management, Logistics planning and management, Cross-functional coordination- Risk-Based Monitoring (RBM): Strategy development, Monitoring oversight, Technology implementation support- Stakeholder Communication and Reporting: Stakeholder and KOL engagement, Progress reporting, Regulatory authorities communication

25Sep2024: Relationship Management workshop: Sponsor Oversight:- Evaluate ideal practices for overseeing your clinical partners - How and when is the ideal time to establish these practices?- Which functional areas are clinical trial sponsors responsible for overseeing? What does sponsor fulfillment of these responsibilities look like in practice?26Sep2024:Trial Design Innovation: Optimizing Clinical Trials Post-Pandemic Through Efficient Trial Design

Leopardstown, Dublin, Ie

Manage all aspects of FIH through Phase III global oncology clinical trials for various sponsors (start-up through large pharma).

Morrisville, Nc, Us

Nashville, Tn, Us

Global phase 1 platform protocol for the treatment of relapsed/refractory aggressive non-hodgkin’s lymphomaGlobal phase 1 protocol for the treatment of non-small cell lung cancer (NSCLC) and other solid tumors

Raleigh, North Carolina, Us

• Proposal and Bid Defense preparation, support, attendance and follow-up• Simultaneously managed, provided operational expertise and leadership for all study start-up and operations activities for 1 Phase I FIH oncology study and 1 Phase I FIH Rare Disease study• Managed project budget, including routine scheduled forecasting, related metric reviews and change order processing• Identified and contracted study-appropriate vendors, including imaging, lab materials, patient reimbursement, travel concierge, EDC, sample processing, drug storage and distribution• Led and directed cross-functional team leaders and third parties/vendors, including prioritizing, trouble-shooting and contingency planning• Provided regular reporting on project metrics, status of deliverables and risks/issues with the associated management plan to client and applicable internal team members• Primary liaison with clients, vendors, and other PRA functional areas• Provided oversight to all aspects of monitoring: site qualification, patient recruitment strategies, patient safety, data quality, ICH/GCP, and adherence to local regulations• Liaised with functional leads/managers to optimize performance and utilization of project team members and funds• Owned and managed project contractual deliverables• Provided study-specific therapeutic training• Supervised study progress and mitigated risks via routine ongoing scheduled metric reviews• Contributed to positive team dynamics through active effective listening and communication• Positively collaborated with study team to ensure all project tasks met client and PRA expectations and were delivered in accordance with the contract, trial protocol, ICH-GCP, applicable SOPs and applicable regulatory requirements• Supervised progress and mitigated risks via routine scheduled metric reviews• Monitored and ensured adherence to the contractual agreements• Contributed to development and approval of project plans

Princeton, New Jersey, Us

Utilized my skill-set, experience and cross-departmental team efforts to recruit protocol eligible patients into clinical trials while managing patient recruitment vendor services and budgetsFocused actions include:• Functional project lead• Responsible for the internal patient recruitment and engagement team and vendor budgets• Managed monthly clinical trial project projections• Per study vendor identification, screening, feasibility, set-up and management to ensure study-specific timely delivery of services while remaining within the agreed budget • Worked with key cross-departmental internal and external stakeholders while non-vendor related deliverables were initiated and managed - such as CRA training, Site Specific Recruitment Plan (SSRP) design, study team training and site completion, surveys, RFI and RFP support, bid defense support and proposal support• Offered oversight to all Covance Patient Recruitment and Engagement projects, including LabCorp and Chiltern studies• Managed and added daily content to the proactively self-created Patient-Centric Oncology Clinical Trials Yammer Group (800+ cross-company followers)

Princeton, New Jersey, Us

• Simultaneously managed 3 U.S. oncology studies (phases 1 through 3), CRAs and study deliverables to meet Sponsor timelines with top patient safety, quality, regulatory compliance and CSP adherence.• Coached sites on development and utilization of the CSP-specific per-site patient recruitment and retention strategies. (Phase I Study: Patient Recruitment and Retention); (Phase II-IIII Studies: Patient Retention)• CRO respresentative to work with Sponsor contacts and vendors for 3 oncology clinical trials.• Managed and reconciled 3 oncology clinical study budgets and invoiced time in order to ensure CRO work was completed within the CRO-Sponsor agreed contract.• Facilitated CRO-Sponsor project agreement updates.• Directed and managed eTMF, CSR and study system (LabCorp, eParexel, RAVE, ClinPhone, ERT ECG, ERT/PHT ePRO) reconciliations. • Created and distributed routine correspondence to U.S. sites.• Mentored staff on professional development.• Started, managed and added routine posts to the internal Patient-Centric Oncology Trials Yammer group.

• Trained and managed 100+ U.S. sites on all aspects of study operations, including the protocol, systems, recruitment and retention. • Designed, implemented and managed overall study and site-specific recruitment initiatives, including detailed site-specific recruitment plans and tools. • Prepared and presented bi-monthly WebEx/teleconferences to train 200+ study personnel, at 167 sites throughout the United States, on study areas that require additional attention based on cumulative study data review. • Provided personal training to site physicians and new site staff via WebEx/Teleconferences. • Developed and implemented training manuals, videos, slide decks and tools. • Presented and discussed study operations and recruitment at Investigator’s Meetings and Conferences. • Organization and analysis of all collected study data in order to identify areas that require a greater amount of attention to recruitment initiatives. • Provided one-on-one guidance to Canadian and Japanese Study Operations Leaders on effective recruitment and retention strategies and approaches to overcoming common protocol challenges. • Participated in routine discussions with Operations Leaders from other participating study countries regarding target endpoint goals and challenges, protocol challenges and recruitment and retention successes and strategies.

• Ensured patient safety, quality data and compliance within trial deadlines.• Managed 8 moderate to severe Psoriasis (Phases II-III) clinical investigative sites and staff and 9 pediatric Crohn’s disease (Phases II-III) clinical investigative sites and staff.

Through precise organization, prioritization and positive motivation, ensured patient safety, quality and that the company and investor clinical trial benchmarks were met prior to deadlines, within budget and in accordance with the protocol, ICH and FDA regulations. Achieved the targeted patient recruitment and retention goals 3 months before the expected timeline.

Highlights:• Assisted sites with targeted patient recruitment and retention strategies. The targeted patient recruitment goal was achieved 3 months before the targeted due date.• Full reconciliation of 140 patient time points, that were outstanding for over 1 year, successfully completed within 16 hours. In order to resolve this dilemma, I proactively flew to the site, asked to be trained on image copying equipment and stayed at the site until I had copied and submitted the images for all outstanding time points.• Effective repair of damaged relationships between the Sponsor and 3 site CRCs and between site CRCs with other site staff, which increased quality and timely productivity.• Exceeded the corporate data and imaging collection goal, with 100% query resolution, 1 month before data lock.

Brentford, Middlesex, Gb

University Park, Pa, Us

Conducted drug development research using Maestro and Jaeger to locate 22 Co(II) Metalloprotein structures. Configured and analyzed the molecular environment that promotes Co(II) Metalloprotein to exist in a stable low-spin state within a biological setting.

Philadelphia, Pa, Us

• Viewed and analyzed films of patient's hearts to locate target areas and reason for diagnosis.• Reviewed patients’ medical history prior to the invasive operations.• Attended cardiac, general internal and reconstructive surgical procedures.• Observed physicians as they diagnosed cases and spoke with patients prior to and following the procedures.

Bachelor Of Science (B.S.), Life Sciences

Human Subject Assurance Training (Modules 1-3)

Quality Assurance/Regulatory Affairs