Career Category

Job Description

Global Study Operations - Site Management (GSO-SM): Clinical Trial Oversight Manager

Key Responsibilities  

• Performs sponsor oversight activities of Functional Service Provider (FSP), including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials.
• Collaborates closely with FSP Line Manager to ensure appropriate level of their staff oversight is deployed.
• Supports FSP staff onboarding and training
• Supervises staff involved in local site contracting and budget management, insurance and payment process as a line manager
• Point of escalation for all stakeholders to support resolution of issues e.g. quality, staff turnover and performance concerns
• Works with FSP vendor(s) to ensure timely and appropriate planning, resource and capacity management from study start up to close-out
• Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships
• Supports inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution
• Organizes and leads regular meetings with FSP and any other country-level project review meetings, if applicable.
• Involved in local and global site management and cross-functional stakeholder collaboration
• Actively participates in role forums including local and global functional and cross-functional initiatives

Qualifications

• Bachelor’s Degree or the equivalent (BSc is preferred)
• Broad work experience working in life sciences or medically related field, including clinical trial site management experience, obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in people management or project management role at regional level in South East Asia and Taiwan in clinical trials
• Experience working with or for FSP or Contract Research Organizations
• Experience of contract and budget negotiation and management

Knowledge

• Familiarity with advanced concepts of clinical research
• Extensive knowledge of ICH/GCP regulations and guidelines, and local regulations in SE Asia and Taiwan
• Strong knowledge of clinical trial operations
• Understanding of FSP operational model
• Relevant therapeutic area education and training

Competencies

• Leadership skills, ability to lead and influence in a positive manner
• Demonstrated ability to work independently with minimal supervision
• Ability to work effectively in a team/matrix environment on multiple projects
• Excellence in relationship building
• Strong interpersonal skills
• Excellent organizational and planning skills
• Excellent oral and written communication in English and Mandarin
• Attention to quality and detail
• Ability to identify and resolve problems
• Flexibility
• Ability to write and present clearly using scientific and clinical issues terminology
• Attention to quality planning and execution
• Ability for critical thinking and thinking out of the box