Requirements: English
Company: TFS HealthScience
Region: Milan , Lombardy
TFS HealthScience is a leading global midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing, and functional service (FSP) solutions.Position OverviewAs part of our SRS / FSP team, you will be dedicated to a global leader in implantable hearing solutions.ResponsibilitiesMonitor onsite and remote clinical trials in accordance with TFS and/or client company SOPs, FDA regulations, GCP, and ICH guidelines.Review CRFs (paper or electronic) and subject source documentation for validity and accuracy; generate queries to investigational sites/clients to resolve data issues.Identify site problems/deficiencies and report to management via trip reports, memos, or verbal communication with the Project Manager or Lead CRA.Initiate corrective actions as directed by supervisors.Assist in the preparation of ethics submissions, including documentation for Ethics Committees/IRBs, in cooperation with CTA and under the guidance of Lead CRA/Project Manager.Participate in contract handling and negotiations as directed.Set up and maintain Investigator Site Files (ISF) and Site Management Files (SMF), and distribute to investigational sites.Order, ship, and reconcile clinical supplies for study sites.Support site staff in maintaining SMF and reviewing Informed Consent documents for compliance.Update CTMS with site and study information.Audit data in clinical summaries, tables, and text as needed.Assist in preparing study documentation such as CRF Completion Guidelines and patient diaries, ensuring accuracy and completeness.Prepare check requisitions for sponsor approval when applicable.QualificationsBachelor''s Degree preferably in life sciences, nursing, or equivalent.Minimum of 12 years of experience as a CRA, with experience in medical devices considered a plus.Ability to work in a fast-paced environment with changing priorities.Understanding of medical terminology and therapeutic areas.Knowledge of GCP, ICH guidelines, and clinical trial regulations.Ability to work independently and within a team.Excellent communication and organizational skills.What We OfferWe provide a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth within a collaborative environment that values innovation and making a difference in patients'' lives.About UsFounded over 27 years ago in Lund, Sweden, TFS HealthScience is a full-service global CRO with over 800 professionals operating in more than 40 countries. We specialize in tailored clinical research services across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core valuesTrust, Quality, Passion, Flexibility, and Sustainabilityguide our decision-making and organizational culture, fostering innovation, excellence, and mutual respect.Key SkillsClinical trial management, regulatory compliance, site management, data review, communication skills.Employment DetailsType: Full TimeExperience: 12+ years as CRAVacancy: 1Location: Milan, Lombardy, Italy#J-18808-Ljbffr