Global Safety Manager at AMGEN S.r.L this role is to provide a management or supervisory responsibility for a sub-team or subset of activities within the local affiliate Safety, whilst reporting to the primary safety responsible person in the relevant country/countries. This Affiliate Safety Manager - Technical will show a good grasp of safety related activities within the local affiliate, demonstrating very sound understanding of GRAAS policies and procedures, local regulations and practices, deputising for country safety lead when necessary, and linking with functions in the local affiliate to meet business needs.

As part of the Amgen Global Patient Safety (International role) . For all Amgen studies conducted in EEA region governed by EU CTR the EU safety Submission Specialist is responsible for: Distribution of ASR / USM / UEIBR via CTIS - collation and submission of Safety-related RFIs - to mantain current knowledge od and compliance with EU CTR and CTIS.

This role demonstrates a good working knowledge of Amgen's policies, procedures and systems and practical understanding of legislation which applies to safety practices locally. Effective operation performance is based on ability to conduct core operational activities based on competent knowledge of safety terminology, database use and tools needed to handle and submit individual and period safety reports. The role also requires the ability to develop a broad understanding of how local safety supports both Amgen Global Patient Safety and the local business.

This role allows for the conduct of specific core safety activities for safety including data collection, processing and distribution within the relevant local country/countries, based on appropriate training and assigned roles within the safety database and related systems, under closer supervision of Safety Manager. To maintain compliance with local legislation and Company policies. To assist the Safety Manager in providing the full range of safety activities to support the local business, including safety training, participation in local medical teams providing safety information.

Responsible for local protocol and site feasibility assessment. Locally plans, executes, manages and reports on Amgen sponsored studies. Single point of contact at a project level for LOC staff and GSM. Selects sites for all Amgen sponsored trials. Approval of Monitoring Reports and Site. Initiation Packages (SIPs). Approval of local clinical study invoices. Issue escalation from findings from sites Setting local goals for Amgen sponsored trials

Contribute to design and preparation of draft ICF template, ensuring Local content is added; Assist in the conduct of feasibility assessments for new clinical protocols; Contribute to identification and selection of clinical investigator; Work with the COM and (SA)COM colleagues to formulate a comprehensive recruitment plan for each new project; contribute to development of study specific processes including study communication plans; participate in identifying study related issues, and work with COM and COSMO to initiate corrective actions when necessary; With the study-specific COM, plan and conduct monthly project review meeting in order to update all Managers on study progress, issues and planned resolutions; Participate in local team meetings, task forces and liaise with Global Study Team ir required; Identifying and reviewing process issues with the clinical development group and recommending improvements when required; Act as back up to COMs when required; Coordinate & actively participate at local investigators meetings; Review CQA Site audit reports and work in conjunction with FSP staff and Site staff as required to fix issues, Partners with Medical colleagues to exchange site relationship information and to develop Key Opinion Leader. (KOLs), Be the primary responsible for studies with solo project management responsibility (eg. Phase 4, follow up and extension studies).

Primary responsible of 6 AMGEN international studies. Also working on other 2 studies in support of COM.

2 years of experience (Oncology Therapeutic Area); international clinical trials Phase II (4) Phase III (3) and site selection for one Phase 1b study; Performing site selection, initiation, monitoring and close-out visits. Monitor visits and site management for a variety of protocols (8 protocols, 5 products, up to 15 sites); Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues; Evaluate the quality and integrity of study site practices; Escalate quality issues to Clinical Operating Manager (COM) and Manager Clinical Field Operations (MCFO) and/or line manager (Study Manager UK or USA).Since Dec 08: Field Base activity.

2 years of experience (Oncology Therapeutic Area); international clinical trials Phase II (4) Phase III (3) and site selection for one Phase 1b study; Performing site selection, initiation, monitoring and close-out visits. Monitor visits and site management for a variety of protocols (8 protocols, 5 products, up to 15 sites); Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues; Evaluate the quality and integrity of study site practices; Escalate quality issues to Clinical Operating Manager (COM) and Manager Clinical Field Operations (MCFO) and/or line manager (Study Manager UK or USA).Since Dec 08: Field Base activity.

Observational study feasibility; Ethical Committee submission; periodic report to Medical Leader Sales Force and to corresponding Business Unit Marketing.