Nisha Ojha
- Role
- Senior Project Manager, Car-t Oncology at Arcellx, Inc
- Location
- Germantown, MD, US
- LinkedIn followers
- 500 followers
Experience
Senior Project Manager, Car-t Oncology
Jul 2022 — Present
Managed and directed studies, ensuring compliance with protocols, timelines, and regulatory requirements throughout study design to closeout. • Collaborated with cross-functional teams to gain comprehensive understanding of program activities, ensuring effective communication of risks and proactive resolution of issues. • Led study design and management, providing valuable input for high-quality protocols, amendments, and informed consent forms. • Developed and maintained strong relationships with investigator sites, CROs, vendors, and consultants to ensure seamless trial execution and deliverables were met. • Improved project efficiency by establishing realistic team deliverables, budgets, schedules, and performance standards. • Provided critical clinical operations input to various clinical documents, such as investigator brochures, protocol, INDs, and clinical study reports. • Actively participated in identifying key risk indicators (KRIs) to monitor clinical data resulting in the implementation of targeted SDV (tSDV) and overall reduction in monitoring cost. • Participated in the development of study-related documentation, standard operating procedures (SOPs) and process improvement tools and contributed implementation and training. • Contributed to strategic and operational initiatives, providing valuable input to improve the efficiency and effectiveness of Clinical Operations.
Education
Towson University
Bachelor of Science in Nursing (BSN/RN)/Biochemistry minor
Syracuse University
Certificate in Project Management
Skills
- Pharmaceutical Industry
- Project Management
- Emar
- Risk Assessment
- Pharmacology
- Ekg
- Trial Management
- Business Analysis
- Tmf
- Management
- Oncology Clinical Research
- Clinical Monitoring
- Advance Cardiac Life Support
- Time Management
- Medical Terminology
- Teamwork
- Basic Life Support Cpr
- Public Speaking
- Good Clinical Practice (Gcp)
- Webex
- Critical Thinking
- Quality by Design
- Patient Advocacy
- Oncology
- Agile Project Management
- Data Analysis
- Dod Financial Management (Fm) Certification
- Patient Education
- Patient Recruitment
- Customer Service
- Business Development
- Standard Operating Procedure (Sop)
- Imedidata® Edc
- Protocol
- Clinical Development
- Risk Based Monitoring (Rbm)
- Clinical Trial Management System (Ctms)
- Patient Satisfaction
- Bi Publisher
- CRO
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