Clinical Trial Oversight Manager

1 mese fa

Milano, Italia Amgen A tempo pieno

**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. Through this program, you will acquire the valuable hands-on skills and foundational experience to become the professional you are meant to be in your chosen field.

**Clinical Trial Oversight Manager (CTOM)**

**LIVE**

**This could be your everyday**

Let’s do this. Let’s change the world. During this program you will:
Performs sponsor oversight activities of SM-FSP, including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials.
- Collaborates closely with SM-FSP Line Manager (FSPLM) to ensure appropriate level of their staff oversight is deployed.
- Supports SM-FSP staff onboarding and training
- Supervises staff involved in local site contracting and budget management, insurance and payment process
- Manages SCBA onboarding and training
- Point of escalation for all stakeholders to support resolution of issues on quality, staff turnover and performance concerns
- Works with SM-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 the Functional Management Team (FMT) Meetings 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**

**Here’s what it takes to Win**

**Basic Qualifications**:

- Doctorate degree OR
- Master’s 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 mínimal 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**

**for an internship that defies imagination**

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

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