Julie Marella
Director, Global Clinical Operations
- Role
- Director, Clinical Operations at Daiichi Sankyo US
- Location
- Warren, NJ, US
- LinkedIn followers
- 500 followers
About Julie Marella
Accomplished, results-driven director with extensive experience in the health care and pharmaceutical R&D industry. Proven ability to successfully lead global and US teams in study execution, to effectively manage a clinical operations department and to facilitate efficiencies and standardization working in a matrix structures.Specialties: Clinical Operations Leadership and Management for phase 1-4 clinical studiesCRO ManagementLine Management Experience with HA sponsor inspections and inspection-readiness best practicesBLA/NDA submissions and approvalEarly phase Clinical Development strategy and planning, pre-IND, SAD, MAD studies, Process Improvement & OptimizationCompliance managementCreating a culture that engages and motivates staff to achieve bottom line results
Experience
Director, Clinical Operations
May 2024 — Present · Basking Ridge, NJ, US
Education
Rutgers University
Mini-MBA- BioPharma Innovation Certificate Program
2008 — 2008
Fairleigh Dickenson University
Business studies
2011
Deaconess College of Nursing
Bachelor of Science in Nursing, RN
Skills
- Biotechnology
- Clinical Monitoring
- Clinical Trial Management System (Ctms)
- Standard Operating Procedure (Sop)
- Ich-Gcp
- CRO
- Regulatory Affairs
- Oncology
- Clinical Trials
- Clinical Development
- Infectious Diseases
- Pharmaceuticals
- Pharmaceutical Industry
- Sop
- Fda
- Good Clinical Practice (Gcp)
- Clinical Research
- Edc
- Therapeutic Areas
- Ctms
- Clinical Operations
- Healthcare
- Drug Development
- Gcp
- CRO Management
- Cross-Functional Team Leadership
- Electronic Data Capture (Edc)
- Health Authority Inspections
- Clinical Trial Management
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