Shivali Suri
Manager, Trial Support @Boehringer Ingelheim
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WORK HISTORY
Manager, Trial Support @Boehringer Ingelheim
Burlington, ON, CA
Leadership role in Clinical Operations Management Team to strategically develop and implement innovative plans, programs and procedures that promote trial execution excellence• Oversee and manage Clinical Trial Operations Specialists, and Clinical Trial Coordinators to ensure clinical trial start up, conduct and close out is optimized• Strategic oversight of trial support to international and local clinical trials, collaborative discussions and initiatives that ensure inspection readiness • Monitoring of key performance indicators for quality assurance, provide input to global SOPs/policies• Establish a high-performance environment through cultivation of organizational values, contributing to innovation and growth• Collaborate with cross-functional teams in Clinical Development Operations, ensure capacity planning, resource allocation, and strategic assessment of pipeline and upcoming trials • Subject matter expert in regulatory trial start up, engaging trial teams and CRO partners to deliver trials with execution excellence
EDUCATION
Government Medical College, India
Bachelor of Medicine, Bachelor of Surgery - MBBS
McMaster University
Applied Clinical Research
Government Medical College, India
Doctor of Medicine - MD
ABOUT SHIVALI SURI
Highly motivated clinical research professional with 15 years of experience in management of clinical trials. Strong background in clinical study delivery, driving successful execution from protocol development to study closeout, ensuring compliance with ICH/GCP guidelines and industry regulations. Proven expertise in vendor/CRO management, risk identification and mitigation, budget control, and cross-functional collaboration to deliver high-quality clinical trials on time and within budget. Adept at coordinating investigational product supply, managing trial documentation (Trial Master File), and optimizing study processes for efficiency. Worked as Clinical Research Associate (CRA) for Investigator Initiated Trials (IITs). Global clinical research experience in managing projects in multiple countries. Worked with multiple sponsors, Investigator Initiated Trials (IITs) and also in Functional Service Provider (FSP) model. SOCRA and PMP certified demonstrating commitment to excellence in study execution. Applied Clinical Research graduation from McMaster University. Internationally trained Medical Doctor (MBBS and MD). Proficiency in Microsoft applications- Outlook, Word, Excel, PowerPoint with strong analytical skills and attention to detail. Excellent problem solving and decision-making skills with ability to prioritize multiple tasks to meet deadlines. Possess excellent communication and presentation skills along with ability to collaborate with diverse team members. KEY QUALIFICATIONSClinical Study Management | Regulatory Document Preparation | Vendor & CRO Management | Global Study Delivery | Clinical Study Planning | Clinical Supply Chain Management | Risk Identification & Mitigation | Trial Master File Management | Budget & Invoice Management | Compliance & Quality Assurance | Project Management | Process Improvement Initiatives | Clinical Development Knowledge | ICH/GCP Compliance | Clinical Research Associate (CRA)| Communication & Relationship Management | Leadership & Team Collaboration
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