Clinical Trial Oversight Mgr

2 weeks ago

Singapore Amgen Full time

Career Category

Clinical

**Job Description**:
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 Development Operations Manager in Singapore.

Live

What you will do

As the Development Operations 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 Development Operations 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:_
- Country/hub leader of Global Study Operations / Site Management (GSO-SM) organization that is accountable for timely, quality clinical study delivery. Actively partners with cross-functional stakeholders to support R&D strategy.
- Review and approve Operational Projections, Baseline and Revised Enrolment Plans
- Represent GSO-SM in internal and external stakeholder interactions & participate in external engagement activities (e.g. pharma associations, Consortiums)
- Point for escalation for resolution of complex clinical study related issues & risks identified
- Lead delivery of pipeline molecule programs & Ensure timely, quality communication to both functional / cross-functional teams to support clinical study execution
- Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness
- Support internal/affiliate and site audits and regulatory inspections & support local and global process improvement initiatives
- Engage local cross-functional teams to maximize local support of clinical studies

Win

What we expect of you

**Qualifications**:

- PhD/PharmD will be considered based on individuals’ 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 obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
- Previous management experience of direct reports, including management level staff
- Strategic operational planning and cross-functional leadership
- Analytical and problem-solving skills

Thrive

What you can expect of us

As we work to develop treatments that take care of otherswork 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

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