Clinical Trial Oversight Manager

HOW MIGHT YOU DEFY IMAGINATION?

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 Trials Oversight Manager in Taipei.

Clinical Trial Oversight Manager

Live

What you will do

As the Clinical Trials Oversight Manager, you will be responsible for aligning and leading the country/hub in accordance with Amgen strategy and driving "One Amgen" approach whilst supporting local and global process improvement and transformational initiatives. The Clinical Trials Oversight Manager will be accountable locally for execution of local clinical trials, risk mitigation and quality management and the performance management of local staff and oversight of GSO-SM Functional Service Provider(s) (FSP)

Main 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.

Involves 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

• PhD/PharmD is not mandatory but will be considered based on the individual's profile.
• Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
• Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience acquired working on clinical trials at a biotech, pharmaceutical or CRO company)
• Preferred experience in managing teams or direct reports, with leadership roles, but not mandatory.
• Required experience in strategic operational planning and working with cross-functional teams.
• Analytical and problem-solving skills.

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.

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.