Dedicated Associate Director with more than 20 years of experience in clinical research.Responsible for the oversight of a team of Observational Research Specialists (ORS) and Line Managers. This includes ensuring successful delivery study deliverables, on time with quality. Responsible to resource observational studies with suitably developed professionals and to retain and develop these professionals within Parexel. Responsible to promote new business by participating in project bids and client presentations as appropriate.In charge for line management of 3 Line Managers covering EMEA countries other than coordinatingdirectly Italian and Nordics ORS teams

As Manager of Observational Research is responsible for the Italian team of Observational Research Specialists, Sr. Observational Research Specialists and Observational Research Leaders. Furthermore in charge to supports new business (proposal development and bid defenses), to support customer initiatives related to observational/non-interventional research. Responsible for the development of processes and procedures and improvement in processes and procedures.

As manager of Contract Personnel Service, MC is in charge for some countries in Europe: Austria, Bulgaria, Czech Republic, Estonia, Hungary, Greece, Italy, Latvia, Portugal, Poland, Romania, Russia, Slovakia, Slovenia, Turkey Ukraine. Responsible for recruitment and Line Management of resources. Local contact for CPS requests, in charge for resource selection and allocation. Direct supervision of non-study related task, financial and project management. Responsible for business development from bid defense with client to financial agreement finalization. First point of escalation for mentioned countries.MC was involved 0.3 FTE since May 2006 as CPS manager, for recruitment and coordination of CPS project for Italy; moved to CPS full time starting from 1st October 2011.

As Manager Global Research Operations, On-Site Monitoring: Management team to meet client expectations by recruiting, retaining and developing a skilled, experienced and motivated team of CRAs and CRAssistants. Ensure employees meet personal goals and objectives by developing appropriate orientation/induction, performance review and development plans. Maintain level of productivity/billability and staff turnover. Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating. Performance and salary review processes. Appropriately reward and recognize team members. Timesheets revision and produce monthly reports. Quality Control/Technical Support

As Senior CRA, MC worked in accordance with ICH Guidelines, monitor guidelines and SOPs. Main tasks performed are: Project coordination for designated studies. Administration and full site responsibility for clinical studies according to Covance Standard Operating Procedures and Good Clinical Practice Guidelines, collection & preparation of documentation for regulatory/EC approvals, contracts review & negotiation, sites activation, monitor at sites, write reports visits and contact regularly the sites. Maintain update the Files in house and at site, collaborate with other departments for reporting safety information, source data verify & collect Case Report Forms.Follow up and solve data queries, report the progress of the study on a regular basis to the PCRA/ Sponsor, perform QC of files, follow up on Investigators Payment. Management of the local study team, Sponsor contact, internal and external teleconferences, review of reports, study status updates.

As Senior CRA, MC worked in accordance with ICH Guidelines, monitor guidelines and SOPs. Main tasks performed are: collection & preparation of documentation for regulatory/EC approvals, contracts review & negotiation, sites activation, monitor at sites, write reports visits and contact regularly the sites. Maintain update the Files in house and at site, collaborate with other departments for reporting safety information, source data verify & collect Case Report Forms.Follow up and solve data queries, report the progress of the study on a regular basis to the PCRA/ Sponsor, perform QC of files, follow up on Investigators Payment. Management of the local study team, Sponsor contact, internal and external teleconferences, review of reports, study status updates.

As CRA MC worked in accordance with ICH Guidelines, monitor guidelines and SOPs. Main tasks performed are: sites identification & selection, collection & preparation of documentation for regulatory/EC approvals, contracts review & negotiation, sites activation, monitor at sites, write reports visits and contact regularly the sites. Maintain update the Files in house and at site, collaborate with other departments for reporting safety information, source data verify & collect Case Report Forms.Follow up and solve data queries, report the progress of the study on a regular basis, perform site close-out visits & QC of files, follow up on Investigators Payment.Attend all study related meetings & TC internal & external.