Observational Research Study Manager Full Time

England, United Kingdom | Bachelor's Degree | 5 - 7 years | Full Time | Male or Female | Research | Biotechnology

Job Summary

Amgen is looking for a Clinical Research Study Manager to oversee and manage the operational activities related to planning, implementation and reporting of observational research executed by GSM. The position sits within our Global Development Organization which, through operational excellence in clinical trials works to deliver high-quality clinical evidence to advance our pipeline and comply with requirements of relevant bodies. The Role Deliverables: •Lead and manage all aspects of the execution of regional/multi country/global observational research studies in accordance with agreed timelines and budget •Identification and resolution of issues and ensures study updates are provided to relevant stakeholders as appropriate •Ensure delivery of observational research studies to agreed quality standards •Planning and tracking of country level performance and managing issues related to execution •Oversee the identification, selection, set-up, and management of vendors, including approval of invoices, scope of work/specifications •Matrix and line management, mentoring and training of staff •Contribute to observational study process development activities, including input into and/or review of SOPs, manuals and training materials

Job Requirements

The Successful Candidate will have: • BA/BS/BSc or RN qualification •Substantial clinical research experience including management and oversight of multi country clinical trials •Previous experience of managing observational research studies •Previous team leadership experience •Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, etc.) •Knowledge of international regulatory and ethics requirements •Experience of collaborating and leading cross-functional teams in a matrix environment •Managed complex projects and juggled priorities across multiple countries and time zones Preferred Qualifications The person who succeeds here will have: •Excellent interpersonal skills •Positive can-do attitude •Resilience and results driven approach

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