Hazel Dcruz
Senior Clinical Project Manager @MAC Clinical Research
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WORK HISTORY
Senior Clinical Project Manager @MAC Clinical Research
GB
Responsible for the overall coordination, implementation, execution, control and completion of projects ensuring consistency with strategy, commitments and goals.Provision of project management leadership to cross-functional teams by integration, facilitating, coordinating and managing all activities related to the initiation, planning, execution, monitoring and closeout of assigned projects and programmes.Responsible for managing projects to ensure integration, coordination and consistency of processes throughout the project life-cycle.Coordination and management of the activities ensuring all budgetary requirements, timelines and target deliverables are met and maintain the risk impact assessment.Prepare and submit IRB/IEC and MHRA application(s), resolving conflicts, determining appropriate follow up until receipt of final approval. Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents and any updated or amended regulatory documentation. Mentoring the project management team with co-ordinating the study feasibility and site selection process.Utilise risk management methodologies to identify risks and work with the team to develop mitigation and contingency plans.Lead the Sponsor meetings, KOM,vendor management.Prepare and lead the Dose Escalation/SRC meetings for early phase studies.Identify, document and manage project risks related to project management function.Support business development activities and support in Bid Defence meetings
EDUCATION
Don Bosco High School and Junior College
High Secondary, science
Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Bachelor of Pharmacy (B.Pharm.), Pharmacology / CLinical Research
Sinhgad Institute of Pharmaceutical Sciences, Lonavala
Masters of Pharmacology, Pharmacology
SKILLS
ABOUT HAZEL DCRUZ
Dynamic and results-driven Senior Clinical Project Manager with over a decade of experience in the pharmaceutical industry, specializing in full-service projects for the past three years. Passionate about delivering high-quality outcomes with a strong focus on process optimization, regulatory compliance, and quality assurance.Possess a robust understanding of ICH-GCP guidelines and extensive expertise in managing clinical trials across all phases (Phase 1-3), including early-phase First-in-Human studies and late-phase trials. Proven track record in leading and facilitating Regulatory CTA submissions, ensuring seamless site readiness, and managing project budgets, forecasting, and deliverables.Key achievements include supporting a high-impact COVID-19 trial study and excelling in critical activities such as screening, randomization, Patient Recruitment, ICF customization, and regulatory filing, from the start up to close out. Skilled in leveraging tools like AQWAs, SAP finance systems, and Clinical Trial Management Systems, Veeva, MS Project Plan to streamline operations and enhance team productivity.With a Master’s in Pharmacology and a steadfast commitment to excellence, I thrive in fast-paced environments where I can inspire teams, drive innovation, and contribute to advancing life sciences. Looking to continue making a meaningful impact in clinical research and drug development.
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