Ismael Busto Pastor
Manager Clinical Trials @BioNTech SE
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WORK HISTORY
Manager Clinical Trials @BioNTech SE
London, GB
Key Responsibilities & Achievements:Status Reporting: Prepare and present regular status reports to ADCO, SDCO, and CMO, updating on project progress and milestones.Budget Oversight: Manage and monitor trial budgets, ensuring efficient use of resources and adherence to financial plans.Project Coordination: Communicate with Project Managers and ADCO to address deviations from project plans and ensure alignment.Timeline Management: Oversee timelines and ensure project deliverables meet established schedules.Document Setup and Oversight: Develop and oversee essential study documents, including the Trial Management Plan and Monitor Manual.Document Review: Review key study documents, such as the synopsis, investigator’s brochure, and informed consent forms, ensuring accuracy and compliance.Activity Coordination: Coordinate project activities with internal departments and external vendors from start-up through close-out phases.Team Supervision: Supervise and guide Clinical Trial Coordinators, CRAs, and CTAs to support successful trial execution.Problem Resolution: Act as the main contact for resolving issues during clinical trial operations.Training Support: Assist in planning and conducting project training sessions, ensuring thorough team preparation and oversight.Selected Achievements:Enhanced Budget Control: Implemented budget management strategies that optimized resource allocation and reduced spending variances by 10%.Improved Documentation Accuracy: Standardized document review processes, enhancing compliance and reducing review times by 15%.Streamlined Communication: Established regular reporting protocols, ensuring timely updates and fostering alignment across departments.
EDUCATION
Universidad Complutense de Madrid (UCM)
Bachelor's degree, Biology/Biological Sciences, General
SKILLS
ABOUT ISMAEL BUSTO PASTOR
As a seasoned Clinical Trial Manager with over 10 years of experience in leading successful global trials, I specialize in orchestrating complex clinical studies from conception to completion. My career spans renowned Pharma, CRO, Biotech, and CDMO organizations, providing me with a diverse skill set and a deep understanding of the clinical trial landscape.At EarlyHealth Group, I led cross-functional teams, managed budgets, and ensured regulatory compliance, consistently delivering projects on time and within budget. In OPIS s.r.l. and ONO Pharmaceutical Co, Ltd, I excelled in vendor selection, negotiation, and management, streamlining supply chain operations and achieving a 15% cost reduction.In my roles at Adamed Pharma and Biontech, I enhanced vendor management processes, improving data accuracy by 15% and achieving 100% protocol adherence. At Biontech, I oversee project timelines, budget oversight, and regulatory compliance, enhancing supply chain efficiency by 20%.Collaborating with regulatory professionals, I have facilitated the preparation and submission of regulatory documents, ensuring adherence to GMP, GCP, GDP, and other standards. My commitment to quality management ensures all clinical trial aspects meet the highest standards.My tenure at DOCS and ICON plc involved meticulous data management and risk mitigation strategies. I have a proven ability to identify potential risks, develop mitigation plans, and ensure accurate data collection and analysis.Key Achievements:Managed global clinical trials with budgets exceeding $5 million, ensuring timely completion and client satisfaction.Led a cross-functional team in developing an innovative drug management tool, enhancing clinical trial supply management efficiency.Played a pivotal role in successful bid defense meetings, securing high-value contracts and fostering strong client relationships.I hold a Bachelor\'s degree in Biological Sciences, majoring in Health Biology from Universidad Complutense de Madrid (UCM), and have completed advanced courses in Clinical Trial Design, Management Operations, Data Management, and Quality Assurance from Johns Hopkins University.Passionate about driving clinical research advancements, I am dedicated to ensuring the success of every clinical trial I oversee. Let’s connect and explore how my expertise can contribute to your clinical research initiatives.
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