Owns and achieves interim and final contractual deliverables throughout the entire project life for assigned projects, according to the time, quality/scope and cost constraints.Leads and directs cross-functional teams, understands and manages client expectations/needs to achieve client satisfaction. Proactively identifies, resolves/mitigates and escalates risks and/or issues. Adheres to PRA standard procedures and processes. Qualified project managers may act as the Global Project Manager in international projects. Consequently, accomplished PMs may provide oversight to other members of the project management group.In Drug Safety/Pharmacovigilance: Responsible for achieving successful delivery of safety and risk activities on assigned standalone projects, by meeting internal and external client requirements according to time, quality, scope, and budget constraints. Serves as a safety representative during the business development process.

Owns and achieves interim and final contractual deliverables throughout the entire project life for assigned projects, according to the time, quality/scope and cost constraints.Leads and directs cross-functional teams, understands and manages client expectations/needs to achieve client satisfaction. Proactively identifies, resolves/mitigates and escalates risks and/or issues. Adheres to PRA standard procedures and processes. Qualified project managers may act as the Global Project Manager in international projects. Consequently, accomplished PMs may provide oversight to other members of the project management group.In Drug Safety/Pharmacovigilance: Responsible for achieving successful delivery of safety and risk activities on assigned standalone projects, by meeting internal and external client requirements according to time, quality, scope, and budget constraints. Serves as a safety representative during the business development process.

• The Clinical Team Manager (CTM) is accountable for achieving successful delivery of clinical activities (site selection, site start up and site monitoring) by meeting internal and external (client & regulatory) requirements according to time, quality/scope and budget constraints.• The CTM leads and directs cross-functional teams and understands/manages client expectations. The CTM proactively identifies, resolves/mitigates and escalates risks and/or issues. • Project Oversight & Leadership: leads and manages the clinical team; works with the PM to facilitate cross functional team and sponsor communication; provides performance / project status metrics; identify issues and risks to clinical activities and develops contingency / mitigation plans; • Project Resourcing: takes active part in clinical resource request; liaises with Clinical Operations Managers to resolve resource and performance issues; effectively manages clinical resources; • Training & Development: creates clinical project documents; plans, oversees, and conducts specific training for the team, responsible for site monitoring activties (tracking and resolution of issues, review and approval of reports, co-monitoring visits, tools prep.). • Quality: supervises IP accountability, subject screening/enrollment, CRF retrieval, and query resolution; ensures all project reporting systems are up to date for the clinical part; collaborates with QA to identify sites needing corrective and preventative action plans, responds completely and accurately to audit reports • Project Finance: provides Time Entry Guidelines to the clinical team in adherence with scope / budget, forecasts units / hours / generic resources for start up and monitoring activities•Customer Relations (Internal & External): interfaces with other Functional Leads, vendors and client as required to ensure clinical monitoring outcomes are achieved; serves as primary liaison for clinical monitoring issues.

• Assisting the Project Manager (PM) in managing study activities in adherence with ICON SOPs, ICH GCP and appropriate regulations• Assisting in the development and implementation of a detailed project plan, as required.• Organizing resources to accomplish special projects and assignments• Mentoring and training of staff, including the ability to provide regular constructive feedback.• Disseminating timely and accurate information on study issues • Accurately addressing issues and/or questions involving SOPs, project materials and/or processes, • Assisting the PM with site assignments• Ensuring the Trial Master File is up to date• Assisting in collating information for the PM and/or client• Participating in or overseeing the development of study related documents• Leading and/or actively participating in the conduct of team meetings• Participating in client meetings, teleconferences and/or general communications• Communicating and escalating of issues to PM• Implementing quality standards, ensuring compliance with study metric requirements as set by the contract and PM and proactively resolving issues• Ensuring data is properly and accurately entered in the CTMS systems• Developing and generating study tracking reports from (CTMS/IVRS/DM)• If appropriate, serving as a secondary client contact and back-up for the PM during periods of absence, as agreed with the PM.• Proactively highlight potential CRA workload issues to his/her manager.• Maintaining confidentiality of management information• Participating in business development activities• As appropriate when deputizing for the PM for periods of absence:-Effectively managing the budget for designated countries through regular review and approval of travel requests, indirect costs and milestone payments-Managing study activities in accordance with the contract and alert his/her global director to any potential out of scope activities or other deviations from the contract

Knowledge of SOPs/WPs, ICH-GCP and local regulations.Recruitment of investigators.Independent and proactive coordination of all activities required to set up and monitor a study:-Identify investigators.-Help in preparation of regulatory submissions.-Design of patient SIS/ICFs.-Coordinate documents translation, verification and back translations.-Ensure timely submission of all documents for IEC approval.-Pre-study, initiation and regular monitoring visits-Maintain all files and documentation pertaining to studies.-Motivate investigators-Complete accurate status reports.-Ensure the correct storage of drugs and accountability-Keep the project manager regularly informed.-Process case record forms-Deal with Sponsor generated queries-Participate in feasibility studies-Ensure the satisfactory close-out of sites-Maintain patient and sponsor confidentiality-Assume additional responsibilities as required-Participate in mentoring new staff.

In the last two years I’ve been a three people team coordinator aimed to monitor two local observational oncological studies. Both studies gathered 1000 patients each.As coordinator I’ve been employed in maintaining job’s relations with Sponsor’s staff. -involved in Investigators’ Meeting planning and carrying out.-Newsletters and Informative report drafting.-actively cooperation with Data Management taking place in web-based e-CRF production.-maintained relations with Scientific Board, opinion Leader and Hospital staff.-followed trial start up and contacted IEC.-monitored fifteen Centres following them from trial start up to Data Base lock.-monitored some trials in different therapeutical areas: an international trial in haematological disease, a local trial in infectious disease and a postmarketing Otolaryngological disease trial.

Protoplast fusion and gene recombination in the uncommon Actinomycete Planobispora rosea producing GE2270.Vicuron Pharmaceuticals S.r.l., Gerenzano, Italy. J Antibiot (Tokyo). 2007 Jul;60(7):447-54.AbstractAn efficient method for protoplast generation for the uncommon actinomycete Planobispora rosea, the producer of the thiazolylpeptide antibiotic GE2270, was developed using a combination of hen egg white lysozyme and Streptomyces globisporus mutanolysin. This method converted more than 70% of vegetative mycelium to protoplasts, which were then regenerated with 50% efficiency in an optimized medium. When P. rosea protoplasts were efficiently fused, recombination between different antibiotic (streptomycin and gentamicin) resistance markers originated sensitive strains (str(s)gen(s)) at frequencies as high as 18% and double resistant fusants (str(r)gen(r)) at frequencies as high as 29%. Double resistant fusants showed GE2270 productivity intermediate between the productivity of the parental strains. Protoplast generation and fusion in P. rosea makes whole genome shuffling feasible as an approach to be used alternately with classical random mutagenesis in industrial strain improvement programs.