Andreea Savan

About Andreea Savan

Clinical Project Manager with comprehensive experience leading global studies phase 1–4 in accordance with ICH/GCP and all applicable regulations, from startup through close-out within biotech and CRO environments. Skilled in overseeing cross-functional teams and external partners, managing budgets and vendor partnerships, and ensuring inspection-ready quality aligned with study objectives. Proven track record of delivering studies on time while optimizing resources.

Experience

1. Clinical Project Manager, Global Clinical Operations

   Syneos Health

   Jan 2024 — Present · San Diego, CA, US

   Managed the execution of global or local clinical studies (Phase 1 to 3) from study startup through delivery and study close out, in adherence to ICH-GCP, appropriate SOPs, and FDA regulations/EU Directive.• Lead the completion of all initial project planning tasks, including creating a Project Plan, identifying project needs with clear timelines, preparing and delivering the Kick-off Meeting (KOM), and creating vendor partnerships and contracts.• Oversee and lead the development, review and finalization of project-related documentation (Study Manuals, Source Documents, Plans) ensuring compliance with relevant regulatory requirements.• Provide supervision of project team, ensuring efficient communication, task delegation, execution and coordination of clinical research projects.• Provide scientific protocol level training, strategic guidance, and support to responsible study team members.• Lead the delivery of Home Nursing services including overseeing the project team, liaising with all internal stakeholders on visit management, oversight and management of project related vendors, and ensuring delivery of the project until completion, escalating issues, and troubleshooting routine inquiries.• Develop, manage, and update the project risk management and mitigation plan throughout the life cycle of the project. • Manage all financial processes for each project and their scope of work.• Lead the forecasting, and reporting of financial activity and monitor project timelines, deliverables, and milestones, ensuring adherence to timelines and budgets.• Lead the clinical study budgeting and site contracting process with the legal team.• Perform accurate and timely review and approval of project invoices.• Lead the project issue management through effective investigation, reporting, and follow-up of corrective actions in collaboration with relevant stakeholders. • Lead inspection readiness activities for FDA and other applicable regulatory body audits.

Education

• Babes-Bolyai University

  Bachelor of Science (B.S.), Biology

  2005 — 2008

• Babes-Bolyai University

  Master of Science (M.S.), Biophysics and Biomaterials

  2008 — 2010

• University of California, Berkeley

  Clinical Laboratory Science/Medical Technology/Technologist

  2014 — 2015

Skills

• Fda Gmp
• Good Laboratory Practice (Glp)
• Iso
• Peer Reviews
• Cleaning Validation
• Corrective and Preventive Action (Capa)
• Pharmaceutical Industry
• Sop
• Laboratory Skills
• Sample Preparation
• Pcr
• Laboratory Information Management System (Lims)
• U.s. Food and Drug Administration (Fda)
• Aseptic Processing
• Quality Control
• Gmp
• Lal Testing
• Uv-Vis Spectroscopy
• Validation
• Capa
• Gel Electrophoresis
• Environmental Monitoring
• Regulatory Affairs
• Microbiology
• Biotechnology
• Change Control
• Raw Materials
• European Pharmacopoeia
• Standard Operating Procedure (Sop)
• Serial Dilutions
• Life Sciences
• Calibration
• Qualty Management
• Laboratory
• Cell Culture
• Aseptic Testing
• Analysis
• Nucleic Acid Extraction