Clinical Trial Oversight Manager

Clinical Trial Oversight Manager

Singapore

Live

What you will do

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Clinical Trial Oversight Manager in Singapore.

Live

What you will do

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

Win

What we expect of you

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

Thrive

What you can expect of us

As we work to develop treatments that take care of others so we work to care for our teammates’ professional

and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits