Study Liaison Manager

Job Description

What you will do Lets do this. Lets change the world. In this vital role you will Accountable for the development of Global Patient Safety (GPS) strategy for safety-related organized data collection in Amgen clinical trials in compliance with global regulatory requirements and Amgen compliance policies and standards. Accountable for the review, approval, and execution of GPS safety data collection strategy across clinical programs (e.g. interventional, observational research, non-Amgen sponsored clinical research, post-trial access, expanded access, etc.). Responsible for participating in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical programs for all Amgen products. Job Summary The Manager works on projects and process that ensures the strategies of the department are driven into the safety related organized data collection activities in Amgen clinical activities to ensure Amgen remains aligned with global safety legislation and requirements Provides input to Clinical teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into Amgen studies activities/programs that may generate reportable safety event information Accountable as liaison between clinical trial and Global Patient Safety to ensure capture of all reportable safety event data generated by such programs and activities Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Key Activities Participates in the creation and dissemination of appropriate safety reporting language in clinical trial key documents, such as study protocols, contracts, safety management plans, and investigative site study guidance documents Supports the department by being a liaison between clinical trial and Global Patient Safety to ensure capture of all reportable safety event data generated by such programs Support activities to ensure GPS input to clinical study initiatives Accountable for vendor oversight of clinical reconciliation activities to ensure reporting of all reportable safety event data within teams remit Actively participates in cross functional projects that develop and support strong cross-functional relationships and communication Develops and communicates plans/objectives to others as needed Maintains knowledge of adverse event reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods Contributes to projects which involve the implementation of new processes and methods within and across Global Patient Safety Maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Provide input to GPS contracting groups globally Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Performs other duties related to the position as vital as defined in Standard Operating Procedures or as requested by their supervisor. Basic Qualifications: Doctorate degree and 2 years of directly related experience OR Masters degree and 4 years of directly related experience OR Bachelors degree and 6 years of directly related experience OR Associates degree and 8 years of directly related experience Or High school diploma / GED and 10 years of directly related experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: Able to effectively represent ideas both verbally and in writing Sound knowledge of the global safety environment, regulations, and guidance Project and/or Process Management experience & knowledge Sound understanding of safety data capture, representation, and interpretation Sound knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Able to apply multi-disciplinary knowledge and understanding to effectively collaborate and negotiate within function and cross-functionally Able to organize, plan and prioritize workload for the function