Ivan Sanchez Email & Phone Number

Hayward, Ca, Us

Los Angeles, Ca, Us

Indications Experience: Uveal Melanoma, Renal Cell Carcinoma, Acute Myeloid Leukemia, Accute Lymphoblastic Leukemia, Non-Small Cell Lung Cancer, Pancreatic Adenocarcinoma, Breast Cancer, Soft tissue Sarcoma, Prostate Cancer, Multiple Sclerosis, Epilepsy, and Spinal Muscular Atrophy.

South San Francisco, California, Us

• Performed early operational planning and execution of a phase 2, open label, (Neo)Adjuvant trial for Ocular Melanoma, from site and vendor selection through the study’s first data cut. Efforts lead to first subject enrollment within 6 months of initial study planning. • Provided CRO oversight and direction while driving process improvements in the setting of ambiguity and changing study needs. • Developed and calibrated study SOPs and study manuals for imaging, central lab, and IRT vendors. Performed EDC, IRT and central imaging UATs. • Led ICF, Budget and CTA template development and negotiations, which posed unique challenges as each site required negotiations with both oncology and ophthalmology departments. • Responsible for the procurement of global site ethics committee approvals including the REB (Canada), REC (United Kingdom), various EU locations per EMA guidelines (France, Germany, Italy, Netherlands), and HREC (Australia). • Held weekly meetings with CRO, study vendors and internal cross-functional team members to ensure study milestones and data deliverables were met according to quality standards and were suitable for regulatory submissions.

South San Francisco, Ca, Us

Executed study start up through close out activities for a NSCLC TORC 1/2 Inhibitor and glutaminase inhibitor trial. Responsible for study SOP development and implementation, site material drafting, site feasibility assessments, CRA training and onboarding, regulatory start up, ICF reviews/approvals, monitoring report reviews, Medidata UAT, Trial Master File oversight, central vendor contracting and management. • Collaborated with cross-functional teams to strengthen study operational quality and efficiency. Provided stakeholders with key clinical operations insights and recommendations. • Led and developed a team of 8 CRAs. Evaluated monitoring KPIs including CRF data metrics, trial master file QC reports, and CRA report writing metrics to prospectively identify performance risks and implement mitigation processes. Held weekly CRA meetings to communicate study progress and redirect efforts, as necessary. • Orchestrated close out of a 75-site, Phase 1/2 Renal Cell Carcinoma trial, while ensuring the final TMF was audit ready.

Durham, North Carolina, Us

•Utilizing site data driven metrics and a risk-based approach, monitored a Phase 2/3 acute myeloid leukemia trial & two phase 2/3 relapsed/refractory epilepsy trials, in order to stay prevent site performance issues and protocol deviations.•Provided SWAT coverage across the US for qualification visits on Axial Spondyloarthritis and Ankylosing Spondylitis trials.•Monitored 14 sites on two recruitment challenged studies. Escalated recruitment barriers and successfully implemented strategies to drive subject recruitment.

Verona, Italy, It

•Monitored a phase 1, dose escalation and expansion trial (3 + 3 ) on a first in class investigational product. •Primarily focused on identification of dose limiting toxicities for relapsed/refractory Small Cell Lung Cancer, Triple Negative Breast Cancer, Soft Tissue Sarcoma, or Ovarian Cancer Subjects•Responsible for 3 sites, including the highest enrolling site on the trial

Durham, North Carolina, Us

•Monitored a high enrolling, phase 3, small molecule, pancreatic adenocarcinoma stem cell inhibitor trial across a 12 site allocation. Sites covered west coast and mid-west, including large academic institutions and smaller private clinics with unique study coordinator and institutional challenges

Morrisville, North Carolina, Us

•Identified clinical trial resourcing shortfalls, high risk practices, and protocol deviation root causes, for poorly performing sites. Made targeted workflow recommendations and value propositions, which resulted in site organizational restructuring and the modification of existing site policies. •Provided SWAT coverage on trials covering Prostate Cancer, Foal Segmental Glomerulosclerosis, Acute Myeloid Leukemia, Head and Neck Squamous Cell Carcinoma, and Pancreatic Ductal Adenocarcinoma•Supported, trained and motivated site staff, while presenting site leadership with strategies for preventing staff turnover•Mentored entry level co-monitors seeking to transition into oncology trials and provided swat pre-trial assessment coverage across multiple oncology trials.•Monitored a high enrolling, phase 3, small molecule, pancreatic adenocarcinoma stem cell inhibitor trial across a 12 site allocation.

Durham, North Carolina, Us

•Performed monitoring activities from site selection through close-out in accordance with good clinical practice including, pre-study visits, site initiation visits, interim monitoring visits, and study close out visits. •Recognized by sponsor for ability to preserve site relationships under performance pressure and to prevent study bottle necks that jeopardized trial progress•Trials monitored: a pancreatic adenocarcinoma trial focused on review of GI related adverse events, a non-small cell lung cancer biosimilar trial, and a pediatric spinal muscular atrophy trial, which achieved FDA clearance for orphan drug status.

Dublin, Ie

•Performed pre-study, site initiation, interim and study close out monitoring visits for sponsor initiated clinical trials. •Monitored sites to ensure studies were carried out according to the study protocol, CRO and Sponsor SOPs, applicable local regulations and the principles of ICH-GCP. •Collaborated with study team members to identify site trends and implement corrective and preventative action plans. Motivated site staff members to limit study procedure errors and to provide clarity when needed. •Performed SWAT coverage on cancer trials from start up through close outs ensuring client deliverables were met.•Indications Monitored: Acute Lymphoblastic Leukemia, Non-Small Cell Lung Cancer, Hyperlipidemia, Hypertension, Plaque Psoriasis, MRSA

Los Angeles, Ca, Us

Los Angeles, Ca, Us

Los Angeles, Ca, Us