Robin Schmidt Email & Phone Number
Who is Robin Schmidt? Overview
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Robin Schmidt is listed as Vice President of Clinical Operations at Blue Parachute, a company with 18 employees, based in Ann Arbor, Michigan, United States. AeroLeads shows a matched LinkedIn profile for Robin Schmidt.
Robin Schmidt previously worked as Clinical Operations Consultant Expert at Blue Parachute Group and Clinical Operations Consultant at Ras Excellence Consulting, Llc. Robin Schmidt holds Master Of Science - Ms, Nutrition Sciences from University Of Michigan - Rackham Graduate School.
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About Robin Schmidt
A highly accomplished and top-performing clinical operations expert with nearly 30 years of proven success in leading all aspects of clinical operations. Expertise spans outsourcing management, risk mitigation planning, budget and resource management, process and system improvement, and strategic planning. Excels in managing single- to multi-region Phase 1-4 clinical research programs and has specialized knowledge in CNS, diabetes, gastroenterology, oncology, women’s health, inflammation and pain, cardiovascular disease, ophthalmology, autoimmune conditions, and rare/orphan diseases. Additional expertise working with autologous stem cell therapies. Drives success by leveraging exemplary leadership, technical, and communication skills to achieve corporate objectives while upholding industry-leading standards of excellence. Able to offer a diverse skill set with proven ability to thrive in multiple environments (large pharma, small to mid-size biotech and CRO).CORE COMPETENCIES• Global, multicenter clinical trial execution (planning, oversight, management, and delivery).• Phase 1-4 expertise and hands-on experience/management• Driving innovation and efficiencies into design and execution of clinical trials.• CRO/vendor management (both full-service and single-service outsourcing).• Quality and risk management.• Direct line management (hiring, training, performance appraisals, mentoring).• Recruitment strategy and metrics reporting.• Financial oversight and timeline management.• SOP development and maintenance.• Trial master file (TMF) planning and organization.• Sound knowledge of ICH/GCP, industry standards, and global regulations.
Robin Schmidt's current company
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Robin Schmidt work experience
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Clinical Operations Consultant Expert
Clinical Operations Consultant
Current
Clinical Operations Consultant Expert
Current
Executive Vice President, Clinical Operations / Chief Operating Officer
- Provide strategic leadership and successful delivery of clinical operations across all clinical programs
- Additional responsibilities for corporate business operations, including G&A, Finance, IT and HR
- Represent business and clinical operations through attendance and presentation at quarterly Board of Director meetings
Vice President Clinical Operations
- Assumed primary leadership role for overall clinical operations strategy across multi-phase clinical trials.
- Planned and executed clinical trials and provided strategic and tactical input for clinical development timelines, operational budget, and key performance metrics to meet corporate objectives.
- Drove innovation and efficiencies in design and execution of clinical trials and in adapting correct clinical operating model.
- Facilitated strategy around insourcing, outsourcing, and management of strategic alliances with CROs and external partners.
- Developed and revised service agreements, budgets, and plans to ensure clear definition of vendor/CRO performance expectations as well as high quality of deliverables, in accordance with commitments.
- Led team to exceed recruitment targets in clinical trial for rare disease.
Senior Director Clinical Operations
- Assumed primary leadership role for overall clinical operations strategy across multiple clinical research trials.
- Provided strategic and tactical input to clinical development timelines, developed study-specific goals, and tracked metrics.
- Implemented strategy around insourcing, outsourcing, and management of alliances with CROs and external partners.
- Led efforts to develop and refine processes to govern all clinical operations activities, including vendor selection, operational systems, and related SOPs.
Director, Clinical Operations
- Ensured overall clinical operation execution and delivery of clinical trials.
- Led outsourcing strategy and monitored performance of CROs, vendors, and clinical consultants.
- Implemented risk mitigation strategies to ensure timely achievement of operational milestones.
- Developed and refined operational processes through SOP development and process improvement initiatives.
Associate Project Director, Global Project Management
- Managed interdisciplinary team as project manager, leading team to ensure on-time, on-budget performance.
- Prepared project management plans for client, project personnel, and inVentiv management.
- Oversaw operational deliverables, project finances, resourcing, training, and quality metrics for assigned projects.
- Performed line management of assigned staff (project managers and project-management-associated staff).
Director, Clinical Study Management And Monitoring
- Performed company-wide study management and monitoring functions contributing to clinical trial execution within and across clinical programs, including tracking trial progress, operating budgets, resource management.
- Supervised clinical study managers and CRAs (hiring, training, performance appraisals).
- Assisted with development and/or review of protocols, safety plans, monitoring plans, recruitment strategy, clinical quality plans, and relevant clinical SOPs.
- Selected, developed, and managed personnel to optimize efficiency of clinical trial execution.
Senior Clinical Project Manager
Executed and managed Phase I/II clinical trials. Performed protocol development, CRO/vendor selection and oversight, clinical supply management, monitor supervision, SOP development, TMF organization, due diligence preparation, review/approval of data management plans/statistical plans/monitor plans, and review of TLFs, among other duties.
Senior Clinical Trial Manager
Executed and managed Phase I/II clinical trials. Performed CRO selection (RFI/RFP process), management of project timelines, CRO and vendor management, enrollment tracking and oversight, and cross-functional team communications. Revised and maintained clinical SOPs. Managed project plans and forecasting data, coordination of packaging and distribution of.
Clinical Study Operations
Performed project management of global, multicenter Phase III clinical trials. Executed clinical protocols (study management, data management), timely delivery of project deliverables, vendor management (central lab, recruitment vendors, data management CRO), cross-functional meeting leadership/facilitation, study budget management, and clinical research.
Clinical Scientist
Performed project management of Phase II/III multicenter clinical studies. Assisted with clinical protocol development and implementation, identification of clinical investigators, study budget management, case report form design, subject adverse-event narrative writing, procurement of clinical drug supplies, and clinical research associate oversight.
Senior Clinical Research Associate
Monitored global, multicenter Phase II/III trials. Performed protocol development, investigator selection, case report form development and review, budget management, cross-functional meeting leadership/facilitation, clinical research associate training, and vendor management (CRO oversight).
Clinical Research Associate
Provided CRO services, monitoring global, multicenter Phase II/III clinical trials. Oversaw protocol compliance, query resolution, adverse-event reporting, review and clarification of source documents and case report forms, maintenance of investigators' regulatory files, drug supply compliance/management, and oversight of compliance with company SOPs and.
Graduate Research Assistant
- Supported graduate professor clinical research through direct patient interaction to provide information on research and collect informed consent and biological samples
- Processed biological samples analysis via laboratory HPLC assessment
Robin Schmidt education
Master Of Science - Ms, Nutrition Sciences
Bachelor Of Science - Bs, Biology, General
Frequently asked questions about Robin Schmidt
Quick answers generated from the profile data available on this page.
What company does Robin Schmidt work for?
Robin Schmidt works for Blue Parachute.
What is Robin Schmidt's role at Blue Parachute?
Robin Schmidt is listed as Vice President of Clinical Operations at Blue Parachute.
Where is Robin Schmidt based?
Robin Schmidt is based in Ann Arbor, Michigan, United States while working with Blue Parachute.
What companies has Robin Schmidt worked for?
Robin Schmidt has worked for Blue Parachute, Blue Parachute Group, Ras Excellence Consulting, Llc, Sling Therapeutics, and Millendo Therapeutics.
How can I contact Robin Schmidt?
You can use AeroLeads to view verified contact signals for Robin Schmidt at Blue Parachute, including work email, phone, and LinkedIn data when available.
What schools did Robin Schmidt attend?
Robin Schmidt holds Master Of Science - Ms, Nutrition Sciences from University Of Michigan - Rackham Graduate School.
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