The CSL is a valued operational expert who provides sponsor site oversight for outsourced trials, building relationship and engaging scientifically with investigators and site staff, as well as ensuring cross \-functional collaboration with all key partners and as such ensuring adequate protection of the rights, welfare, and safety of human subjects and the quality of the clinical trial data of these investigational sites. Some of main assigned tasks are:-Maintain relationship with… Show more The CSL is a valued operational expert who provides sponsor site oversight for outsourced trials, building relationship and engaging scientifically with investigators and site staff, as well as ensuring cross \-functional collaboration with all key partners and as such ensuring adequate protection of the rights, welfare, and safety of human subjects and the quality of the clinical trial data of these investigational sites. Some of main assigned tasks are:-Maintain relationship with investigators and clinical trial staff-Discuss clinical programs, trial design, and identify barriers to recruitment (operationally, scientifically-focused discussions)-Perform CRA-accompanied visits and routine oversight visits at the sites-Oversee CRO activities locally-Sponsor oversight of appropriate conduct of the trial and quality of the data through the monitoring of site KPIs-Report and follow-up visits as per CSL guideline(s)-Deliver Site Engagement plan-Drive delivery of studies Milestones within their country. Show less

MSL for Achondroplasia on assignment to Biomarin Italy

• Manage an international staff of CRAs (Based in Poland, Czech Republic and Scandinavian Countries) in accordance with organization’s policies and applicable regulations • Facilitate the professional development of staff, including fostering career growth, and providing support in the form of line management to clinical research associates • Responsible for conducting quarterly employee appraisals and performance reviews and guiding professional development; rewarding and… Show more • Manage an international staff of CRAs (Based in Poland, Czech Republic and Scandinavian Countries) in accordance with organization’s policies and applicable regulations • Facilitate the professional development of staff, including fostering career growth, and providing support in the form of line management to clinical research associates • Responsible for conducting quarterly employee appraisals and performance reviews and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters • Participate in the selection and onboarding process for new clinical staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs • Ensure that staff has the proper materials, systems access and training to complete job responsibilities • Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable • Manage the quality of assigned staff's clinical work through regular review and evaluation of work product • Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff • Supports the delivery and resourcing of EU clinical programs as required by assigning staff to clinical studies that are appropriate to their experience and training • Responsible for effective and cooperative relationship management with key functional business partners to drive business forward • Works with the Senior Director to develop departmental strategic goals in concert with corporate goals, and departmental action plans to meet those goals, and provides recommendations regarding salary adjustments • Active participant in the organization, planning and delivery of staff department meetings Show less

The Clinical Operations Line Manager is the main point of contact for assigned staff members in the region as the direct reporting line and will provide supervision, support, guidance, mentoring, coaching and counselling to those team members on a day to day basis. Primary local point of contact for Client within the country, involved in day to day interaction with the client’s designated representative in all matters related to resourcing, assignment of personnel, employee performance and… Show more The Clinical Operations Line Manager is the main point of contact for assigned staff members in the region as the direct reporting line and will provide supervision, support, guidance, mentoring, coaching and counselling to those team members on a day to day basis. Primary local point of contact for Client within the country, involved in day to day interaction with the client’s designated representative in all matters related to resourcing, assignment of personnel, employee performance and deliverables. Show less

-Business Development support;-Recruitment and hiring process;-Line managment (orientation training, co-monitoring visits, training plan, appraisals);-Local contact for Italian Sponsors;-Mentor for JCRAs.

Duties: monitoring of phase 2 and 3 international trials, submissions to Ethical Committees, feasibilities for an observational study.Therapeutical areas: neurosurgery, neuroradiology, intensive care, dermatology, nuclear medicine

 start-up management (drawing up of CRFs, Investigator manual and informed consent forms) and submissions to Ethical Committees;  support as Junior Clinical study Manager; monitoring of a phase I, II III international clinical trials;  updating of “Standard Operating Procedures” in clinical operations; training and support to other Clinical Monitors (Angelini’s and CRO’s Monitors).Application field : diabetic nephropathy, psychiatry, general care.

duties: monitoring of phase II, III, IV national and international clinical trials following “GCP” and “Standard Operating Procedures” and management of start-up authorizations for two Italian clinical sites.application field: clinical research in dermatology, immunology and metabolic diseases.

duties: clinical monitoring (pre-study, initiation, and routine visits), data entry, management of electronical and papery archives, organization of study meetings, contacts with opinion leaders;application field: no profit trials national and international about medical devices for nephrology and dialysis.