Mariarosaria Rizzi
Clinical Operations Lead
- Location
- Rome Area, Italy
- Industry
- Industria farmaceutica
Come membro di LinkedIn, entrerai a far parte di una rete di 225 milioni di professionisti che condividono collegamenti, idee e opportunità.
- Guarda le conoscenze che hai in comune con Mariarosaria Rizzi
- Fatti presentare a Mariarosaria Rizzi
- Contattare Mariarosaria Rizzi direttamente
Panoramica di Mariarosaria Rizzi
- Attuale
-
- Clinical Operations Lead assigned to Pfizer Inc at i3 presso i3 Pharma Resourcing
- Precedente
-
- Clinical research associate/Local Trial manager presso Novo Nordisk A/S
- Clinical Research Associate presso Sanofi-Aventis SpA
- Data manager and management of clinical trial FASEIII presso University Federico II of Naples
- Pre-clinical research presso University Federico II of Naples
- Collegamenti
-
119 collegamenti
Esperienza di Mariarosaria Rizzi
Clinical Operations Lead assigned to Pfizer Inc at i3
i3 Pharma Resourcing
Privately Held; 1001-5000 employees; Industria farmaceutica industry
June 2011 – Present (2 years 1 month) Rome Area, Italy
A COL works with senior management and provides oversight and support to the clinical operations team in planning, conduct, and closeout of assigned clinical studies.
A COL ensures patient safety and quality study execution in accordance with GCP/ICH, study objectives and Pfizer SOP.
A COL ensures that the Global Research Operations deliverables (timeline, quality, productivity) are met.
Main activities and responsibilities as Clinical Operations Lead at Pfizer:
- overall trial oversight
- sites oversight
- management of clinical trial timelines and project milestones
- execution of clinical trial objectives
- study and procedures training to CRAs and site staff
- protocol and study documents (ICD-Privacy) preparation and quality check
- oversight of the regulatory document collection and submission process
- project progress evaluation by tracking timelines and using tracking/analysis tools (RTII)
- budget management and finance activities for assigned studies
- preparation and conduction of Health Authority (FDA-EMA) Inspection and internal audit
- produce and distribute status, resourcing and tracking reports as well as functional area plan to team members and senior management
- maintain effective communication with the project team through oral and written correspondence, project status reports, and monthly progress reports
- attend project team meetings, clinical committees, clinical monitoring staff meetings and clinical training sessions
- study Transfers to the Alliance Partners oversight and management
Clinical research associate/Local Trial manager
Novo Nordisk A/S
Public Company; 10,001+ employees; NVO; Industria farmaceutica industry
December 2008 – June 2011 (2 years 7 months) Rome Area, Italy
Main activities:
- Country and sites feasibility
- Site selection and site initiation visits
- Submission to EC and HA
- Review of protocol, amendment protocol, clinical trial documents ( Informed Consent form, Privacy, Patient card-Patient diary-SAE form-IP label) and case report forms
- Monitoring visits
- Protocol and site management
- Drug supply management
- Site closeout visit
- Clinical Trial Reports/Clinical Study Reports review
- Management of relationships with main key opinion leader (KOL)
- Sites staff training
- New employee training
- Investigator meeting organization
- Pre-inspection readiness
Clinical Research Associate
Sanofi-Aventis SpA
Public Company; 10,001+ employees; SNY; Industria farmaceutica industry
January 2008 – December 2008 (1 year) Milan Area, Italy
Activity in oncology area:
- site feasibility
- site selection and site initiation visits
- submission to EC and HA
- monitoring visits
- site closeout visit
Data manager and management of clinical trial FASEIII
University Federico II of Naples
Educational Institution; 5001-10,000 employees; Istruzione superiore industry
September 2006 – December 2007 (1 year 4 months) Naples Area, Italy
In particular:
- review of the final protocol
- collaboration with the Health Authority (AIFA)
- management of financial contracts with the site
- management of the EC approvals
- management of the Investigator's trial file and general file
- management of the relationship with the Sponsor
- workshop in the University
Pre-clinical research
University Federico II of Naples
Educational Institution; 5001-10,000 employees; Istruzione superiore industry
September 2003 – July 2005 (1 year 11 months) Naples Area, Italy
Collaboration with University Federico II of Naples for experimental thesis in oncology molecular pre-clinical research.
Lingue conosciute da Mariarosaria Rizzi
-
English
Competenze ed esperienze di Mariarosaria Rizzi
- Clinical Trials
- GCP
- CRO
- Oncology
- Clinical Research
- Sop
- Protocol
- CTMS
- Clinical Monitoring
- ICH-GCP
- Clinical Development
- EDC
- Project Management
- Pharmaceutical Industry
- Therapeutic Areas
- Pharmacovigilance
- Clinical Data Management
- Regulatory Submissions
- Regulatory Affairs
- Vaccines
- Medical Writing
Visualizza tutte le competenze (21) Visualizza meno competenze
Visualizza il profilo completo di Mariarosaria Rizzi per...
- Scoprire le conoscenze che hai in comune con Mariarosaria Rizzi
- Chiedere a qualcuno di presentarti a Mariarosaria Rizzi
- Contattare Mariarosaria Rizzi direttamente
