Study Liaison Manager

The Manager works on projects and process that ensures the strategies of the department are implemented 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

• 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 necessary as defined in Standard Operating Procedures or as requested by their supervisor.

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

• 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