Michelle Jaffe Email & Phone Number

Teaneck, Nj, Us

Manages client expectations and contractual deliverables internally and externally according to time, quality/scope and budget constraints. Leads and manages cross functional teams globally. Proactively identifies, resolves/mitigates and escalates risks and/or issues.

• Ensures that all clinical tasks meet client and PRA expectations, and are delivered in accordance with the contract, trial protocol, ICH-GCP, applicable Standard Operating Procedures (SOPs) and applicable regulatory requirements• Provides timely status reports for the clinical activities on assigned projects• Sets, tracks, and reviews milestones, tasks, timelines and projected hours for all the clinical activities for assigned projects, ensuring adherence to contract and… Show more • Ensures that all clinical tasks meet client and PRA expectations, and are delivered in accordance with the contract, trial protocol, ICH-GCP, applicable Standard Operating Procedures (SOPs) and applicable regulatory requirements• Provides timely status reports for the clinical activities on assigned projects• Sets, tracks, and reviews milestones, tasks, timelines and projected hours for all the clinical activities for assigned projects, ensuring adherence to contract and budget• Reviews and approves monitoring reports and ensures tracking of ongoing issues• Reviews Essential Documents to ensure sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines• Provides data as required for clinical operations performance and project status metrics• Participates in Investigator meetings, assisting with presentations as needed• Contributes to Business Development Activities participating in proposals and bid defenses as needed• Addresses and resolves all internal and external clinical issues for client research projects• Recommends and implements enhancements to clinical systems• Interacts with client(s), vendors and PRA functional areas as primary project contact for clinical issues• Identifies out of scope tasks from clinical team and escalates to the Project Manager• Liaises with Clinical Operations Managers to resolve resource and performance issues• Leads clinical operations team on a project, providing study specific and therapeutic training and mentoring as required Show less

Clinical study manager for Phase I and II prostate cancer and acute lymphoblastic leukemia studies.Project manager for Phase I ovarian cancer study.

Regional Cra

Monitor Phase 1-2 Oncology & Gastroenterology studies.

Tel Aviv, Israel

Clinical study manager and monitor for a Phase 3 Acute Ischemic Stroke study.Trained new CRAs.Coordinated activities worldwide at sites in 18 countries.

Bronx, Ny

Managed the hematological malignancy clinical trials.

- Managed clinical trials data- Formulated source documents- Participated in the design and development of clinical trial protocols, source document templates, and case report forms- Conducted second line site monitoring and close-out visits around the U.S.- Verified source documents- IRB protocol submissions as well as applying for IRB approval- Assisted with the preparation of clinical study reports and resolution of data discrepancies