Career Category

Clinical

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Do more with the knowledge you’re working hard to acquire and the passion you already have. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide.

CLINICAL TRIAL OVERSIGHT MANAGER (Sostituzione maternità)

LIVE

This could be your everyday

Let’s do this. Let’s change the world. In this role you will:

• Perform sponsor oversight activities of SM-FSP, including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials
• Collaborate closely with SM-FSP Line Manager (FSPLM) to ensure appropriate level of their staff oversight is deployed.
• Support SM-FSP staff onboarding and training
• Be a point of escalation for all stakeholders to support resolution of issues on quality, staff turnover and performance concerns
• Work with SM-FSP vendor(s) to ensure timely and appropriate planning, resource and capacity management from study start up to close-out
• Conduct on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships
• Support inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution
• Organize and lead the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable.
• Be involved in local and global site management and cross functional stakeholder collaboration
• Actively participate in role forums including local and global functional and cross-functional initiatives

WIN

Here’s what it takes to Win

We are all different, yet we all use our unique contributions to serve patients. We seek a candidate with these qualifications.

Basic Qualifications:

• Master’s degree OR
• Doctorate degree OR
• BA/BS/BSc or qualified nurse (RN)
• Work experience in life sciences or medically related field, including Biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)

Preferred Qualifications:

• Broad work experience working in life sciences or medically related field, including clinical site management experience, obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience as a CRA, CTA, and/or Clinical/Regional Manager in the biopharmaceutical industry
• Experience in a project leadership role
• Experience working with or for Functional Service Provider or Contract Research Organizations
• Supervisory Experience
• Knowledge of or work experience with a biopharmaceutical GRDCA or QC department

Knowledge and Competencies

• Clinical Research: Familiarity with advanced concepts of clinical research, extensive knowledge of ICH/GCP regulations and guidelines, strong knowledge of clinical trial operations, and understanding of Functional Service Provider operational model
• Technical Skills: Computer and system operation skills.
• Therapeutic Area: Relevant therapeutic area education and training.
• Customer Service: Detailed understanding of customer service and demonstrated ability to anticipate and resolve problems.
• Independence & Teamwork: Demonstrated ability to work independently with minimal supervision and effectively in a team/matrix environment on multiple projects.
• Leadership & Influence: Excellence in relationship building, ability to lead and influence in a positive manner, and strong leadership skills.
• Interpersonal & Communication Skills: Strong interpersonal skills, excellent organizational and planning skills, excellent oral and written communication, and business English fluency.
• Quality & Detail: Attention to quality and detail, ability to identify and resolve problems, and attention to quality planning and execution.
• Problem Solving & Flexibility: Ability for critical thinking, thinking out of the box, and flexibility.
• Scientific Communication: Ability to write and present clearly using scientific and clinical issues terminology

THRIVE

Some of the vast rewards of working here

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.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

APPLY NOW

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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.

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