Clinical Trial Oversight Manager

**HOW MIGHT YOU DEFY IMAGINATION?**:
If you feel like you’re part of something bigger, it’s because you are

At Amgen, our shared mission—to serve patients—drives all that we do, which is the key for us to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together by researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide.

The Global Study Operations team in the Iberia Affiliate is looking for a Clinical Trial Oversight Manager.

**CLINICAL TRIAL OVERSIGHT MANAGER (CTOM)**

**LIVE**:
**What you will do**

Let’s do this. Let’s change the world. In this vital role, you will be the point of contact for Functional Service Provider (FSP) vendors for resource and capacity management, portfolio planning and prioritization, including the identification, escalation and resolution of quality and delivery issues in Iberia. In this role, you will provide support of clinical study execution through an effective collaborative partnership with all stakeholders. You will lead the site contracting/budgeting activity in the territory.

**Key Activities**:

- Performs oversight activities of FSP staff including CRA and CTA performance, delivery and quality metrics in collaboration with FSP Line Managers
- Works with FSP vendor 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 maintenance of Amgen investigator site relationships
- Supports inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution
- Point of escalation for all stakeholders to support resolution of issues eg quality, staff turnover and performance concerns
- Oversight of the site contracting/budgeting activity in Iberia: CTOM supervises the team involved in local site contracting and budget management, insurance and payment process
- Engage local cross-functional teams (Local Trial Managers, Medical, Regulatory, Legal, Compliance) to maximize support of clinical trials
- Actively participates in cross-functional initiatives for process improvement, competitiveness improvement,in Iberia

**WIN**

**What we expect of you**

We are all different, yet we all use our outstanding contributions to serve patients. What we seek in you as an expert professional are these qualifications and skills:
**Basic qualifications**:

- BA/BS/BSc in sciences
- 7 years experience working in clinical site management (working on clinical trials at a biotech, pharmaceutical or CRO)
- Extensive knowledge of ICH/GCP regulations and guidelines
- Strong knowledge of clinical trial operations
- Fluent in English & Spanish, in oral and written communication

**Preferred qualifications**:

- Master Degree
- Broad work experience working in life sciences or medically related field, including clinical site management experience
- Experience as a CRA and min 2 years in Clinical / Regional Manager in the biopharmaceutical industry / CRO
- Experience in working in clinical trials in Portugal
- Understanding of Functional Service Provider operational model
- Relevant therapeutic area education and training

**Competencies**:

- Ability to work effectively in a team/matrix environment on multiple projects
- Ability to lead and influence in a positive manner
- Strong decision-making authority
- Strong interpersonal skills
- Excellent organizational and planning skills
- Attention to quality metrics and study deliverables
- Strong issue and risk management capability

**THRIVE**:
**What you can expect of us**

As we work to develop treatments that look after others, we work to care for our teammates’ professional and personal growth and well-being.
- Vast opportunities to learn, develop and move up and across our global organization
- Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks and act
- Generous Total Rewards Plan comprising healthcare, finance, 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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who res