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Summary

Consolidated knowledge in clinical operations coming from over 10 years of experience in CRO and Pharma Company. Success in leading clinical trials conduction at local/regional/global level to ensure that deadlines, budgets and objectives are achieved on timely manner even under pressure and with challenging deadlines. Focused on Company’s objectives and quality, reliable and honest person with high flexibility to respect the planning and management of the projects. I like working in international, ever adapting and always looking ahead environment. Open mind in analysing situations, evaluating consequences and develop innovative and creative solutions to problems. Possesses good interpersonal communication and negotiation skills with no difficulties in create positive internal and external relationships. Developing experiences as speaker and trainer related to Clinical Operations and Project Management topics both in national and international events. Since 2013 I’m developing manager experience leading team composed by CRAs, Physicians, Clinical Trial Managers, Trial Master File Specialist and Clinical Trial Assistants.

Experiences

Current Experience

  • CRA Manager
    Since January 2014
    Management of a team composed by 5 people (direct reports) located in 2 Countries both office and home based. Responsible for training and yearly assessment of CRAs. Ensure adequate resources allocation to the trial. Acting as point of contact for compliance with SOP and GCP. As CRA Manager: •Creation of a consolidated CRA team with own identity •Creation of a governance system aimed to have the adequate people onboard at each meeting recognized as best practice and implemented in other countries •Led program of training on SOP, GCP and clinical operations both internally and international masters •Led assessment program of the CRAs •Led selection and recruitment of personnel

Past Experience

  • Global Monitoring Organization-Head of Country Italy and Spain ad Interim
    March 2015 --- September 2015
    Ensure that all clinical and regulatory activities conducted in the assigned territory are in line with the company strategic plans, performed according to the highest quality standards and adequate resources allocated. Coordinating trial site activities and responsible for the conduct of clinical trials in the applicable territory within GCP Guidelines and company SOPs. Interacting with study investigators for the trial planning and supporting execution for medical/safety aspects of the trials conducted in the assigned territory. Controlling trial budget within the Countries. Management of a team composed by 17 people (9 direct reports) located in 2 Countries both office and home based including training and development. As Head of Country Italy and Spain •Develop and implement strategy for clinical trials •Budget managed and maintained on track •Site and Office Audits managed without critical findings •Implementation and oversight of CAPA plans •Intercompany transition conducted without any business interruption

  • Senior Clinical Trial Manager
    June 2008 --- December 2013
    Operational Management of CRAs, maintaining relation with Investigators, responsible for monitoring activities, implementation of established monitoring procedures in accordance with GCP, SOPs, ICH, company policies and local regulations, assuring the collection of high quality data and ensuring all timelines are met, team point of contact for compliance. Previous roles covered: Clinical Trial Manager, Clinical Study Coordinator, CRA As Clinical Managing vaccine clinical trials phase I and III national and international. •Submission to Ethic Committees and Competent Authorities •Managing CROs and internal and external CRAs •Managing of the budget •Monitoring sites: site initiation and site staff training, source data Verification; Investigational Product, ancillaries and study documentation management •TMF management (both papery and electronically) •Investigator’s meeting organization (national and international) •Acting as main point of contact between Clinical Operation Department and Data Managers, QA, MW, Head Quarter, Laboratories, Biostatisticians. Research Areas: HCV, Meningitis B, Flu, GBS

  • Clinical Research Associate (CRA)
    October 2007 --- May 2008
    Responsible for monitoring and sites management; management of international clinical studies of phase III and epidemiological trials. As Clinical research Associate. • Monitoring sites: site initiation and site staff training, source data Verification; Investigational Product, ancillaries and study documentation management • TMF management (both papery and electronically) • Submission to Ethic Committees and Competent Authority Research Areas: Immunology: Multicenter, International, Early Access Program of investigational medication in combination with other Antiretroviral drugs in treatment-experienced HIV-1 infected subjects with limited treatment options. Sites allocated:10 Average of patients: 25 Epidemiology: Effects of smoking habits on patients with lung cancer. Start-up and site initiation phase

  • Clinical Research Associate (CRA)
    November 2006 --- October 2007
    Responsible for monitoring and sites management; management of international clinical studies of phase III and epidemiological trials. As Clinical Research Associate. • Monitoring sites: site initiation and site staff training, source data Verification; Investigational Product, ancillaries and study documentation management • TMF management (both papery and electronically) • Supporting submission to Ethic Committees and Competent Authority Research Areas: Cardiovascular and Metabolism: Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the long-term Effect of Treatment with experimental drug vs standard drug in patients with Type 2 Diabetes Inadequately Controlled with Monotherapy. Sites allocated: 10; Average of patients: 6 Oncology: Randomized Open-Label Study of two doses of study drug in Patients with Newly Diagnosed of CML-CP Sites allocated: 2; Average of patients: 5 Oncology: Multicenter, Double-Blind, double dummy study to compare two drugs as adjuvant therapy in post-menopausal women with breast cancer. Sites allocated: 13; Average of patients: 35

  • Fellowship researcher
    January 2005 --- November 2006
    Responsible for conducting and developing strategies of laboratory research projects As Researcher: •Biomolecular assays •Biochemical assays •Cell cultures •Histological techniques, assays and analysis •In vivo technique: surgery in rat and mice

  • Fellowship researcher
    August 2004 --- January 2005
    Responsible for conducting and developing strategies of laboratory research projects As Researcher: •Biomolecular assays •Biochemical assays •Cell cultures •In vivo technique: surgery in mice

  • researcher
    May 2004 --- August 2004
    Responsible for conducting and developing strategies of laboratory research projects As Researcher: •Biomolecular assays •Biochemical assays •Cell cultures

  • Teleseller
    February 2004 --- August 2004
    Management of outbounding calls to sell phone products As Teleseller: •Improvement in verbal/phone communication •Ability to work under pressure in order to meet targets and deadlines. •Ability to work independently as well as part of a team.

  • Fellowship researcher
    November 2003 --- December 2003
    Responsible for conducting and developing strategies of laboratory research projects As Researcher: •Biomolecular assays •Biochemical assays •Cell cultures

  • Junior researcher
    August 2001 --- July 2003
    Responsible for conducting and developing strategies of laboratory research projects As Researcher: •Biomolecular assays •Biochemical assays •Cell cultures

  • Junior researcher
    September 1999 --- July 2000
    Responsible for conducting and developing strategies of laboratory research projects As Researcher: •Biomolecular assays •Biochemical assays •Cell cultures •Electrophysiological techniques

Personality

Self Assessment :
Analytical thinkingAttention to detailCollaborationCompetitivenessCritical thinkingDiligenceCuriosityEmotional reactivityIndependenceProactivityKindnessResiliencyResult OrientedSelf-disciplineWillingness to compromise

Knowledge

LinkedIn Assessment :
Sperimentazioni clinicheSOPmanagementRicercaRicerca clinicaCRORegulatory submissionsMonitoraggio clinicoICH-GCPClinical trialsLeadershipMicrosoft OfficeMicrosoft ExcelMicrosoft WordFormazioneCTMSClinical researchTrainingPowerPointPianificazione, definizione del budget e previsioniGestione del personaleGestione team cross-functionalBuona pratica clinicaEDC INFORM trainerCRA assessorIndustria FarmacéuticaClinical trialsPharmaceutical IndustryGCP

Skills and Expertise

Self Assessment :
GCP trainerCRA assessor

Education

  • Scienze Matematiche, Fisiche e Naturali in Biologia/Scienze biologiche, generale from Sapienza Università di Roma in 2003
  • Diploma scuola superiore in Liceo Classico from Fondazione Cristo Re in 1996

Training and Certification

  • ICH-GCP Certification

Languages

BrightOwl Assessment:
Self Assessment:
Italian
Native
English
Professional Proficiency
Spanish
Full Proficiency

Work Preferences

  • Notice Period:
    6 weeks
  • Positions I am interested in:
    Clinical Operations Manager Clinical Project Manager (CPM) Clinical Project Leader Clinical Research Coordinator Clinical Research Manager Clinical Trial Manager (CTM) Clinical Trial Specialist (CTS) Global Clinical Project Manager (GCPM, GTM) Clinical Director Europe Compliance Manager
  • Locations I am interested in:
    Italy
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Rome, Italy

Others

Driving License
  • Yes